Fall 2014 by McMahon Group

M A ee S tin H se e g P us Iss at bo ue ot h

Bridging the gap between the hospital and alternate-site care Volume 3 • Number 4 • Fall 2014 • specialtypharmacycontinuum.com

In This Issue Up Front

NASP and SPAARx set new path forward.

Clinical

Reintroduced legislation may bolster Medicare coverage

Home Infusion Data Strong, But Pay Lags

Disease state spotlight: rheumatoid arthritis.

Tips for building effective hubs. Finding safe harbors in specialty contracts.

•

Technology

mscripts CEO: why digital drug adherence tools make sense for specialty pharmacy.

See page 7.

The Drug Quality and Security Act

A New Reality for the Practice of Outsourcing Compounded Sterile Preparations See insert after page 12.

see CHEMO PARITY, Y page 19

In U.S. market…

Corporate Spotlight MHA Specialty Pharmacy Solutions

Partisanship killed 2014 federal bill; states still active King of Prussia, Pa.—Federal oral chemotherapy parity legislation is dead, at least for this year, according to Matt Farber, MA, the director of Provider Economics and Public Policy at the Association of Community Cancer Centers (ACCC). However, this and other bills will be reintroduced next year. Part of the reason that it was so difficult to get legislation passed is the “hyper” partisanship of legislators

Operations & Mgmt

13 14

Parity for Oral Chemotherapy On 2015 Agenda

More Questions Than Answers For Biosimilars

Austin, Texas—Should infusion therapy occur more frequently in the home? Two new studies and proposed legislation point to yes, especially if patients are immunocompromised. Home infusion of IV immunoglobulin (IVIG) is associated with significantly lower rates of pneumonia and bronchitis for patients with primary immunodeficiency disorder (PIDD) compared with infusion in an outpatient hospital, according to a study by Baxter HealthCare that was presented at the American College of Clinical Pharmacy’s 2014 annual meeting. Researchers studied records from the Truven MarketScan database of more than 6,000 patients with PIDD who had at least one inpatient or emergency room claim or at least two outpatient claims and at least six months of continuous IVIG claims from the same site of care—home (n=2,006), infusion clinic (n=2,758) or outpatient hospital (n=1,919). They found pneumonia rates of 0.55 per person-year for home infusion compared with 0.67 for the clinic and 1.04 for the outpatient hospital. Bronchitis rates were 0.24 per person-year for the home setting compared with 0.38 for the clinic and 0.59 for the outpatient hospital. Although there are a number of safety components

Orlando, Fla.—Despite the FDA establishing a pathway for approval of biosimilar products and accepting the application from Sandoz to create a biosimilar of filgrastim (Neupogen, Amgen), a lot of talk continues about what this will mean to the U.S. market. At the 2014 meeting of the National Association of Specialty Pharmacy (NASP), a panel of experts had a lot to say about the issue, with most of the comments covering the usual hot topics of potential savings, bioequivalency and impact on hospital formularies. As for the savings that biosimilars will bring to the marketplace over their

see INFUSION THERAPY, Y page 12

see BIOSIMILARS, page 10

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Get the App: Specialty Pharmacy News iPad App

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FDA Watch Obizur approved for rare hemophilia A. See page 13.

Specialty Pharmacy Continuum • Fall 2014

UP FRONT

Merged Trade Associations Set New Path Forward Orlando, Fla.—The merger of the National Association of Specialty Pharmacy (NASP) and the Specialty Pharmacy Association of America (SPAARx) comes at a time when the industry is experiencing double-digit growth and facing many complex challenges, experts noted during the NASP 2014 annual meeting and exposition. “There is no more exciting time to not only be in specialty pharmacy, but to be in health care,” said Mike Ellis, BSPharm, RPh, the president of NASP. The merger “brought two competing forces into a single voice to represent the industry,” added Mr. Ellis, who is also corporate vice president of Specialty Pharmacy & Infusion at Walgreens. The Orlando meeting was an opportunity to bring the organization together and begin to discuss how it will best represent its stakeholders, according to Jim Smeeding, RPh, MBA, the executive director of NASP.

Broad Representation The newly merged group now represents all stakeholders in the industry—the specialty pharmacy provider, manufacturer, distributor, health systems and home infusion, noted Robert Fulcher, CAE, chief operating officer of NASP. Given that new breadth of repre-

sentation, the group is well positioned to address many of the challenges facing the profession, he noted. One such challenge is the high longterm costs of many specialty pharmaceuticals, according to Doug Long, vice

the science. We have to look at what the science says as far as treatment because sofosbuvir is a cure. [Payors] have to allow access to these medications.” But he acknowledged that many of those payors are making patients work

president, Industry Relations at IMS Health. The typical specialty pharmacy patient, he noted, has a complex, chronic disease that requires lifelong, expensive therapies. For patients spending thousands of dollars every year for such treatment, the expense can become a hardship, he stressed. Sofosbuvir (Sovaldi, Gilead) is a case in point, he noted. Third-party payors are particularly concerned about the cost of the hepatitis C treatment, which at $84,000 carries a hefty price tag. But all of the specialty pharmacy experts presenting at the meeting said the concern over the immediate costs ignores the long-term savings, because sofosbuvir cures HCV and prevents the need for a $400,000 liver transplant and lifetime immunosuppressive medications. “Cost is only one piece,” said Lee Goldberg, the director of syndicated research at Zitter Health Insights. “There is also

harder to obtain authorizations. “There is an increased willingness to manage access more restrictively,” he explained. David Coury, PharmD, the vice president of business development at Acro Pharmaceutical Services, joked that managing access means acquiring large amounts of data, including a patient’s favorite color, before granting authorization. “Payors are spending a lot of time making sure it’s the right patient, and he or she will be compliant,” Dr. Coury said. Helping patients navigate those potential minefields of drug coverage and access is one of the most important skills that specialty pharmacy brings to the table, Mr. Ellis noted. In fact, “many of the key services [we] provide have nothing to do with the route of the drug” or other clinical considerations, he said. Rather, “it is about [providing] the right counseling and [ensuring affordable] access to these

potentially lifesaving medications.”

A Focus on Education Proper patient counseling can’t happen, however, without robust continuing education (CE). That’s why providing CE has always been important to NASP and SPAARx, and they plan to continue that focus and expand their CE offerings as a merged association, Mr. Fulcher said. Moving forward, NASP also will be working on the local, state and federal levels to represent specialty pharmacy and help legislators and others understand the critical impact that specialty pharmacy has on health care. As a “new” organization, there is plenty of room for members to participate and a number of committees still need volunteers, Mr. Fulcher noted. In addition, NASP will continue to look for new members and plans a membership drive for the end of the year. “We want to hear from you about what you expect and what you need,” he said. “In the end, NASP is about you, and we represent all stakeholders in specialty pharmacy. We want this to be the place where people come together and get the support that they need.” —Marie Rosenthal

EDITORIAL BOARD

ART/PRODUCTION STAFF

HOME INFUSION

Michele McMahon Velle, MAX Graphics/Creative Director

Jay Bryant-Wimp, RPh Owner/CEO Accurate Rx Pharmacy Columbia, MO

Frank Tagarello, Senior Art Director/Managing / Director, r MAX Graphics James O’Neill, Senior Systems Manager

Randy Fasnacht, RPh Director of Pharmacy Advanced Infusion Services Akron, OH

Dan Radebaugh, Director of Production and Technical Operations

Volume 3 • Number 4 • Fall 2014

specialtypharmacycontinuum.com

Marty Barbieri, Production Manager Brandy Wilson, Circulation Coordinator

SPECIALTY PHARMACY N. Lois Adams, MBA, RPh Chairman, President and CEO Freedom Pharmacy Orlando, FL Randy Falkenrath, MBA Senior Vice President CVS Health Woonsocket, RI

McMAHON PUBLISHING Michael Sicilian President, Managed Health Care Associates, Inc. Florham Park, NJ Donald J. Vidic, RPh, MBA Vice President of Operations and Pharmacy Services Walgreens Specialty Pharmacy Carnegie, PA

Stephanie Holliday, PharmD Clinical Pharmacy Specialist Prosperity Specialty Pharmacy Falls Church, VA Cindy Kunzendorf, PharmD General Manager Accredo/CCS Locations Elmhurst, IL Hetty Lima, RPh, FASHP Vice President of Specialty Infusion Services Diplomat Specialty Pharmacy Flint, MI

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Specialty Pharmacy Continuum • Fall 2014

ASK THE EXPERT

Felicia Schaps of BioScrip

Preventing Catheter Infect T

he Centers for Disease Control and Prevention (CDC) has identified central lin ne– associated bloodstream infections (CLABSI) as the third leading health care– – associated infection. The numbers are in the hundreds of thousands—a review of 200 published studies found that nearly 250,000 catheters become infected per year in hospitals alone (Mayo Clin Proc 2006;81[9]:1159-1171). Mortality rates for these infections range between 12% and 25%, and the excess cost for treating CLABSIs is estimated to exceed $16,000 per patient (MMWR Morb Mortal Wkly Rep 2011;60[8]:243-248; http://goo.gl/RuAAz0). Specialty Pharmacy Continuum recently discussed the common causes of these infections and innovative prevention strategies with Felicia Schaps, BSN, RN, CRNI, the corporate direc ctor of clinical services for BioScrip, a national provider of infusion and home care management service es headquartered in Eden Prairie, Minn.

SPC: Are there particular patients who are at greater risk for CLABSIs? Ms. Schaps: Patients getting nutrition through a central line are at particular risk because of the sugars in the nutrition that are administered through that line. Bacteria love to feed off sugars, and these patients are nutritionally depleted anyway. Also, most of our patients get their products already mixed for them, but patients on parenteral nutrition (PN) have to put additives in while in the home because compounds such as multivitamins are not stable when added in advance. So on a daily basis, s, or a couple of times a week, patien nts or family members are draw wing those up and injectingg them into the bag, which provides an opportunity to inject bacteria that we don’t see with other patients. In the decades I’ve been doing home infusion, we’ve typicallyy seen more CLABSIs amo ong nutrition patients than in cancer c patients, the other highest-risk group. SPC: What are some of the main contributors to CLABSIs? Ms. Schaps: The five most common causes of CLABSIs are: 1) improper cleaning of the skin insertion site before placement procedure; 2) improper cleaning of the catheter hub before entrance; 3) hematogenous seeding from a distant infection; 4) improper hand-washing and or complete lack of hand-washing; and 5) contaminated infusate solutions. In some cases, we have no control over these factors. For example, if the patient has a UTI [urinary tract infection] or an infected joint, there’s not much we can do to prevent the bacteria from going to the catheter. But we can control the techniques we’re using. SPC: Is hand hygiene still a problem, even after all the education that’s out there?

Ms. Schaps: Despite major educational efforts on the importance of handwashing, compliance with hand hygiene practices by health care workers remains around 50%, according to a 2009 report by the Joint Commission, “Measuring Hand Hygiene Adherence: Overcoming the Challenges” (http://goo.gl/wVsjcU). U Patients and nurses alike forget to wash their hands, which is a problem given all of the bacteria present on our hands. Hand-washing is effective when individuals wash before and after contact with a catheter device, the touching of a patient or touching something within the hospitaal room, in the home, in th he nurse’s bag and each an nd every time gloves are rremoved. One last area of concern in relation to improper handwashing is fingernail w c are. Fingernail care is extremely important whe n it comes to hand hygienee. Artificial nails are now considered a big no-no, especially when caring for high-risk patients such as those with cancer and/or intensive care patients. Artificial nails can harbor organisms such as gram-negative bacteria and fungi even after hands are washed. Additionally, chipped nail polish on real nails can permit bacterial growth. For patients who are getting PN, a nurse is not coming in every day to hook it up and take it down. We’re teaching patients and their family members, because it’s just as important for them to understand hygiene as it is for the nurse. But it’s hard to get outcomes data on this because you have no way of knowing what people are doing when you’re not there. SPC: How important is cleaning the catheter hub? Ms. Schaps: Catheter hubs are responsible for approximately 30% of catheter infections ((Ann Clin Microbiol Antimicrob 2003;2:3). Hub manipulation is the most

common cause of catheter infections in patients with long-term catheters, largely because of poor technique and inadequate cleaning. Although there are no complete studies as of today, experts are stating that a 15-second cleaning with alcohol is sufficient. Friction should be used while cleaning the catheter hub and or needleless valve device. Catheter hubs should be changed at least weekly, with the dressing change, and also after each blood draw. SPC: When should antiseptic discs or patches be used? Ms. Schaps: There are several types of antiseptic discs available, including those treated with CHG chlorhexidine gluconate] and also discs impregnated with a hemostatic agent, polyhexamethylene biguanide hydrochloride. Silver-coated discs are also used. CHG has been known to cause hypersensitivity reactions; the silver-coated patches, in contrast, use an ionic silver that is nonirritating. The latter also have been shown to have greater efficacy against certain types of bacteria than CHG patches. Antiseptic patches are used in both home and hospital settings. There was an increase in their usage after Medicare issued a statement that it would reduce or eliminate reimbursement for hospital-acquired infections, which include catheter infections. The patches do not come packaged with the catheters and are a separate purchase, and get changed each time the catheter dressing is changed. There are quite a few manufacturers, but probably the most popular ones are the BioPatch made by Johnson & Johnson, and Medline makes the SilvaSorb disc. But it is important to remember that antiseptic discs or patches are not intended to be used as a preventative measure. They are a treatment for a catheter with redness at the insertion site. If you use a patch to treat redness, with the next dressing change if the site is no longer red, you do not need to replace the

patch. You would continue to monitor the insertion sitee for complications. SPC: What about novel flush solutions, like ethanol locks? Ms. Schaps: Ethanol lock therapy involves filling the catheter lumen with medical-grade sterile ethyl alcohol, allowing the solution to dwell for a prescribed period of time, and then aspirating or flushing the solution through the catheter. It is much more prevalent in home infusion than in hospitals, and is used most often for patients receiving PN, often in response to the patient having already had a catheter infection. Some physicians do use them prophylactically, but the majority are ordered after a catheter infection has occurred and the line was treated or replaced. Ethanol lock therapy has been found to be a safe and effective way of reducing these infections in PN-dependent pediatric patients ((J Pediatr Surg 2010; 45[10]:1961-1966). Here in the [Washington] D.C. area, we work with Children’s National Medical Center and its intestinal rehabilitation unit. The center discharges children with enteral and PN, and they do order ethanol locks on their patients when they are sent home. Many of them have bowel anomalies and a risk for translocation of bacteria, and the ethanol lock makes a big difference. In fact, ethanol locks are now much more common than antibiotic locks, which require you to isolate the bacteria causing the infection and to use an antibiotic lock to treat that bacteria. That obviously happens only after a patient has already had an infection. But ethanol locks can only be used with the right type of catheter because it may cause degradation of certain plastics and catheter materials. You should always verify with the manufacturer that the material in the specific brand of intravascular device will not be harmed by the presence of ethanol for extended dwell times. —Reported by Gina Shaw

Member Success Starts Here

MHA Specialty Pharmacy Solutions is dedicated to optimally position specialty pharmacy members and business partners to succeed in an sp incre creasingly dynamic health care environment. Invested ted in member needs, we can help you maximize opportunities for successs th through our full spectrum of specialty services and solutions including: • Con ontracting • Clinical cal Services and Education • Technology gy Solutions S • Data Collection n an and Reporting • Association and Strategi ategic Partnerships To learn more about MHA Specialty Pharmacy armacy Solutions offerings, visit www.mhainc.com or contact us at 800.642.3020 0 x 2870 or MHASpecialty@mhainc.com.

Specialty Pharmacy Continuum • Fall 2014

MHA Specialty Pharmacy Solutions Helping specialty pharmacy stakeholders enhance the care of their patients and skillfully navigate the specialty landscape

CORPORATE SPOTLIGHT

Specialty pharmacies, pharmaceutical companies and other health care stakeholders must maneuver through a variety of issues that can stand in the way of good patient outcomes. High costs of specialty drugs, limited access to those drugs, everchanging reporting regulations, and the escalating number of specialty therapies and delivery systems all converge to create one of the most complex landscapes in health care. MHA Specialty Pharmacy Solutions (SPS) creates and introduces innovative solutions for specialty stakeholders to help them: • Manage businesses more efficiently • Meet goals to improve their patient outcomes and d profitability • Utilize technology that streamlines processes and enhances productivity • Understand and break through the barriers of an evolving environment

About MHA Specialty Pharmacy Solutions Managed Health Care Associates, Inc. (MHA) is a leading health care services and technology company focused on the alternate site health care provider marketplace. Through the MHA SPS team, specialty pharmacy members and business partners gain access to an ever-expanding portfolio of technology-based solutions, timely and relevant resources, advocacy and education, and clinical and business experts who are on a mission: to empower specialty pharmacy stakeholders to compete and succeed in the increasingly dynamic health care environment. To achieve this mission, the MHA SPS team members: • Partner with specialty manufacturers to implement contracting opportunities • Gather deep, real-time insights from MHA’s extensive membership • Study current and future challenges in the specialty marketplace and identify areas of opportunity for growth and improvements • Deploy account management teams to work with our members With these insights, we bring together our technology, clinical, business and marketing experts to create innovative solutions that meet and exceed the needs of our specialty pharmacy members and business partners.

A Full Spectrum of Specialty Services To provide the greatest support for our members and business partners, MHA SPS offers a full spectrum of expert specialty services, including: • Specialty contracting, with a solid track record of successful development and execution of contracting strategies across 16 therapeutic areas and more than 100 products • Clinical services and education, including a wealth of educational programs, business and provider resources, and direct access to MHA’s Clinical Services team • Data collection and reporting, such as aggregated wholesaler and distributor data, dispensing and clinical metrics, data extraction tools and support, and business analytics • Technology solutions, such as applications for specialty pharmacies that simplify data collection and analytics, improve business efficiencies for prior authorizations, and enhance their patient care • Association and strategic partnerships, connecting business leaders and giving members unique opportunities to interact with key stakeholders and decision-makers across all classes of trade in the specialty market • Accreditation resources, providing members with valuable tools and assessments to navigate the complex accreditation landscape. • Legislative resources, providing members with relevant legislative updates on federal and state level issues in the Specialty market Because we are engaged in one of the most complex areas of health care, our services and solutions continue to evolve. We move at the speed of the market.

Technology-based Solutions One of the innovative solutions within our portfolio is Clinical Therapy Management (CTM), a software application that sets forth a pathway to help pharmacies improve patient care and facilitates collection of essential clinical and dispensing metrics. Through CTM, specialty pharmacy members have an effective tool for communicating with patients and physicians at key intervals during treatment. The application helps specialty pharmacies identify when patients need treatment support, so they can intervene as needed. Throughout the clinical support pathway, the CTM platform facilitates the collection of clinical and dispensing metrics and simplifies specialty data extraction and reporting. Another important solution is MHAuthorizeRx™, a prior authorization (PA) solutions program powered by CoverMyMeds®, to help health care professionals address the challenges that accompany PA requirements for pharmaceutical products, including specialty pharmaceuticals. The secure, web-based tool enables pharmacies to collaborate with prescribing physicians to submit PAs for any drug to nearly all health plans. With a few simple clicks, MHAuthorizeRx creates an automated, paperless experience for the pharmacy and ensures that prescriptions are filled with greater efficiency and with the most up-to-date information from health plans.

High-touch Account Management An experienced, high-touch account management team forms the backbone of all MHA services and solutions. Team members are committed to helping partners navigate a complicated landscape and achieve the goals they set for patients and their businesses.

CONTACT US TODAY To learn more about the services and technology solutions that help our members maximize success, visit www.mhainc.com or contact 800.642.3020 x2870 or MHASpecialty@mhainc.com.

AT A GLANCE Address 25-A Vreeland Road, Suite 200 Florham Park, NJ 07932 Phone: (800) 642-3020 Email: MHASpecialty @mhainc.com Website: mhainc.com

Specialty Pharmacy Continuum • Fall 2014

CLINICAL ???

DISEASE STATE SPOTLIGHT

New Treatments for Rheumatoid Arthritis Courtney Krueger, PharmD, BCPS Clinical Assistant Professor Drug Information Group University of Illinois at Chicago College of Pharmacy Chicago, Illinois

tent inflammation in patients with RA. Rheumatoid factors (RF) and anti-cyclin citrullinated protein antibodies (ACPA) can often be detected before symptomatic RA, but their role is not well described.

Diagnosis

heumatoid arthritis (RA), a systemic inflammatory autoimmune disorder, is estimated to affect 1.3 million American adults and is the most common form of inflammatory arthritis.1,2 Although symmetrical joint involvement is a frequent feature of RA, patients may also experience fatigue, subcutaneous nodules, vasculitis, neuropathy, cardiopulmonary effects, and hematologic abnormalities.3,4 RA can present at any age, with typical symptoms including joint pain or stiffness. One or more joints of the hands and feet are generally affected first.

The American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) have developed criteria for the diagnosis and classification of RA.5 Patients with at least 1 swollen joint whose symptoms are not likely related to another disease are assessed based on the number and type of joints involved, level of antibodies (RF and/or ACPA), presence of acute-phase reactants, and symptom duration. A score of at least 6 out of 10 is considered a definitive diagnosis for RA.

Pathophysiology

Treatment options for RA are typically categorized as either symptomatic treatment, including corticosteroids and nonsteroidal anti-inflammatory drugs (NSAIDs), or disease-modifying antirheumatic drugs (DMARDs). The DMARDs are diverse medications that work via a variety of mechanisms, but all have in common altering the disease course. In addition to the conventional DMARDs, several biologic agents and, most recently, a nonbiologic, small molecule DMARD with a novel mechanism of action, have been approved and recommended for patients with RA. The goal of treatment for RA is either low disease activity or remis-

The cause of RA remains largely unknown; however, both genetic and environmental factors appear to be involved.3,4 Cigarette smoking, in particular, is associated with a dramatic increase in RA risk. Although the pathophysiology of RA is complex and incompletely understood, T lymphocytes and B cells have important roles in the initial immune response, and the end result is inflammation and hyperplasia of the synovial membrane that affects underlying cartilage and bone. The proinflammatory cytokines, including tumor necrosis factor (TNF) as well as interleukin-1 (IL-1) and IL-6, mediate the persis-

Treatment

sion.6 The Disease Activity Score in 28 joints (DAS28) is often used to quantify disease activity.7 Scores range from 0 to 10, with lower scores indicating less active disease. A score of less than 2.6 has been used to define remission in clinical trials; however, the ACR/EULAR developed new criteria for remission in 2011.8 These criteria require a patient to have no more than 1 tender or swollen joint, a C-reactive protein (CRP) level of 1 mg/dL or lower, and a score of 1 or less on the patient global assessment. A Simplified Disease Activity Index score of 3.3 or less may also be considered remission per the updated recommendations. Clinical trials of drug therapy also report ACR20, ACR50, and ACR70 as improvement criteria. These scores represent a 20%, 50%, and 70% improvement, respectively, in both the tender and swollen joint counts as well as improvement in other core measures.9 Conventional DMARDs

Conventional DMARDs include methotrexate, hydroxychloroquine, leflunomide, minocycline, and sulfasalazine.6 Of these agents, methotrexate is generally preferred for most patients with RA. It may be given parenterally or orally; however, recent evidence supports less gastrointestinal toxicity and improved efficacy with the injectable route.10 These agents can be combined with other conventional DMARDs or with biologic agents.6 Routine complete blood counts, liver function tests, and serum creatinine monitoring are recommended with the

Table 1. Conventional DMARDs for Rheumatoid Arthritis3,11,12 DMARDs

Usual Dose Range

Adverse Effects

Special Monitoring

Methotrexate 7.5-15 mg/wk oral/IM/SC (oral doses exceeding 7.5 mg should be divided); higher doses may be used but increase the risk for toxicity

GI toxicity Hematologic toxicity Hepatotoxicity

Baseline testing for ACR does not recommend use hepatitis B and C with a creatinine clearance recommended for <30 mL/min; dose adjustment patients with risk may be necessary in patients factors with a creatinine clearance <60 mL/min

Hydroxychloroquine

200-300 mg orally bid

Ocular toxicity (rare) Allergic reactions GI complaints

Complete ophthalmologic exam within first year of treatment

Use with caution in renal or hepatic impairment

Sulfasalazine

1-3 g/d oral (dose must be titrated; usual dose is 2 g/d in divided doses)

GI complaints Hemolytic anemia Hypersensitivity Myelosuppression

None

Not recommended in renal or hepatic impairment

Leflunomide

10-20 mg/d oral (a loading dose of 100 mg/d for 3 d may initially be used)

GI complaints Hepatotoxicity Alopecia (reversible) Rash Paresthesias

Baseline testing for hepatitis B and C recommended for patients with risk factors

Not recommended in liver disease

Minocycline

100-200 mg/d oral

GI complaints Hepatotoxicity Photosensitivity

None

Use with caution in renal impairment

ACR, American College Colle ege of Rheumatology; GI, gastrointestinal; gastrointestin nal; IM, intramuscular; SC, subcutaneous subcu utaneous

Comments

use of methotrexate, leflunomide, and sulfasalazine. A summary of these agents is provided in Table 1. Biologic Agents

The majority of biologic agents for the treatment of RA inhibit tumor necrosis factor-α (TNF-α), α which is an important cytokine for promoting inflammation.3,6,12 Other biologics inhibit IL-6 or IL-1, deplete peripheral B cells, or prevent T cells from becoming fully active. The following paragraphs provide a brief summary of the various biologic agents for the treatment of RA, and dosing information can be found in Table 2. TNF-α Antagonists

TNF-α α antagonists were first approved for use in RA patients in 1998, and currently there are 5 available.21 Four of these agents—infliximab (Remicade, Janssen Biotech), adalimumab (Humira, AbbVie), golimumab (Simponi, Janssen), and certolizumab (Cimzia, UCB)—are monoclonal antibodies, and etanercept (Enbrel, Amgen) is a soluble TNF receptor.22 Trials that directly compare TNF-α antagonists with one another are lacking. A 2012 meta-analysis found minimal difference in efficacy among the agents, all with similar efficacy to methotrexate.22 The combination of methotrexate with a TNF-α α antagonist was superior to either agent as monotherapy in this analysis. Etanercept appeared to have an improved tolerability profile compared with the other agents, as the risk for discontinuation due to an adverse event was lower. Other TNF-α α antagonists had either higher or similar rates of discontinuation due to adverse events (AEs) compared with controls. A 2014 meta-analysis also supported lower discontinuation rates due to AEs with etanercept compared with other TNF-α α antagonists.23 Interleukin Receptor Antagonists

Anakinra (Kineret, Sobi), an IL-1 receptor antagonist, is approved for RA treatment in patients who have failed at least 1 DMARD; however, it is not included in the most recent ACR or EULAR guidelines because of lack of strong efficacy data.6,24 Anakinra must be administered daily as a subcutaneous injection.25 Further discussion of this agent is limited, as it is infrequently used. Tocilizumab (Actemra, Genentech), an IL-6 receptor antagonist, is approved as monotherapy or in combination with a DMARD for RA treatment in patients who have failed at least 1 DMARD.20 It may be given as an IV infusion monthly or as a subcutaneous injection weekly or every other week. Tocilizumab monotherapy was recently

Specialty Pharmacy Continuum • Fall 2014

CLINICAL ???

Table 2. Biologic Agents for Rheumatoid Arthritis.12,13-20 Usual Dose

Comments

TNF-α antagonists Adalimumab

40 mg SC every other week (may increase to 40 mg/wk in patients not taking concomitant methotrexate)

May be used as monotherapy or in combination with nonbiologic DMARDs

Certolizumab 400 mg SC on day 1 and weeks 2 and 4 then 200 mg every other week or 400 mg/mo Etanercept

50 mg SC/wk

May be used as monotherapy or in combination with methotrexate

Golimumab

50 mg SC/mo 2 mg/kg IV at weeks 0 and 4, then every 8 wk

Approved in combination with methotrexate

Infliximab

3 mg/kg IV at weeks 0, 2 and 6 then every 8 wk (may increase up to 10 mg/kg or treat as often as every 4 wk in patients who fail to respond)

Other biologics Abatacept

IV dose is weight-based (<60 kg = 500 mg; 60-100 kg = 750 mg; >100 kg = 1,000 mg) given on days 1 and at 2 and 4 wk then every 4 wk 125 mg SC/wk (can administer with or without IV loading dose)

May be used as monotherapy or in combination with non-TNF DMARDs

Rituximab

1,000 mg IV days 1 and 15; may repeat every 24 wk

Approved in combination with methotrexate after inadequate response to at least 1 TNF-α antagonist

Tocilizumab

4 mg/kg IV every 4 wk (may be increased to 8 mg/kg every 4 wk) SC dosing is weight based (<100 kg = 162 mg every other week; ≥100 kg = 162 mg/wk)

May be used as monotherapy or in combination with nonbiologic DMARDs after inadequate response to at least 1 DMARD

DMARD,, disease-modifying y g antirheumatic drug; g SC,, subcutaneous; TNF,, tumor necrosis factor

compared with the TNF-α antagonist adalimumab, in a large randomized controlled trial.26 At 24 weeks, tocilizumab resulted in greater improvement in mean DAS28 scores than adalimumab (–3.3 vs –1.8); however, increased cholesterol and aminotransferases as well as decreased neutrophil counts were more commonly reported with tocilizumab. T-Cell Costimulation Modulator

Abatacept (Orencia, Bristol-Myers Squibb) is a fully human recombinant protein that disrupts the pathway for T cell activation.18 It is the only agent with this mechanism and is available as either an IV infusion administered monthly (after the initial 3 doses given at 2-week intervals) or a subcutaneous infusion at weekly intervals. It has been directly compared with both infliximab and adalimumab in clinical trials with similar efficacy outcomes; however, fewer serious AEs and infections were reported with abatacept than infliximab.27,28 Abatacept has also been shown to be effective in patients who have failed TNF-α α antagonists.29 Studies indicate that abatacept is effective when used in combination with conventional DMARDs such as methotrexate, but abatacept should not be used in combination with biologic DMARDs because of increases in serious AEs.30 Anti-CD 20 Antibody

Rituximab (Rituxan, Genentech) is a monoclonal antibody that facilitates the destruction of B cells.19 It is specifically approved for use in combination with

methotrexate after failure of TNF-α antagonists. Recent studies indicate that rituximab may be more effective for patients who have failed an initial TNF-α agent than switching to an alternative TNF-α α antagonist, especially in patients who are switched due to inefficacy of the TNF-α antagonist.31,32 Rituximab must be given by IV infusion, but it is administered infrequently (every 24 weeks) after the first 2 doses. Patients must be premedicated with a corticosteroid, an antihistamine, and acetaminophen to minimize infusion-related reactions.19 Tofacitinib

Tofacitinib (Xeljanz, Pfizer) is the only janus kinase (JAK) inhibitor approved for use in the United States. JAKs are intracellular enzymes that ultimately affect both hematopoiesis and the function of immune cells.33 Tofacitinib is currently FDA-approved as an oral treatment for RA patients who failed methotrexate. It can be used either alone or in combination with conventional DMARDs. The recommended dose is 5 mg twice daily for most patients, but those taking potent inhibitors of cytochrome P450 3A4 and those with renal or hepatic impairment may require a lower dose of 5 mg daily. A trial comparing combination therapy with methotrexate and tofacitinib to methotrexate with adalimumab found similar improvement in disease scores with either option.34 In addition, a recent study showed tofacitinib monotherapy to be superior to methotrexate monotherapy in reducing signs and symptoms of

RA in patients who were methotrexatenaive.35 The most common adverse reactions with tofacitinib include diarrhea, headache, nasopharyngitis, and risk for infection.33

Rx Guidelines for DMARDs Both the ACR and EULAR have recently updated their practice guidelines on the use of DMARDs.6,24 Patients who have early RA (disease duration <6 months) with any disease activity level and without poor prognostic factors should be treated with DMARD monotherapy.6 Patients with high disease activity but no poor prognostic factors may also be treated with the combination of methotrexate with hydroxychloroquine. Combination DMARD therapy should be used for patients with medium or high disease activity and poor prognostic factors. Alternatively, patients with poor prognosis and high disease activity may be treated with a TNF-α α antagonist with or without methotrexate. Patients should be reassessed after 3 months of therapy (although 6 months may be required for newer biologics), at which time treatments may be added or changed. Patients who are treated with one TNF-α α agent may be switched to another agent in the class unless a serious adverse event occurred with the initial TNF-α α therapy. The EULAR guideline specifically recommends inclusion of methotrexate as part of the initial treatment for patients with RA without contraindications.24 Tofacitinib is not included in the most recent ACR guideline because it was not

FDA-approved at the time of guideline development.6,36 EULAR did include tofacitinib in its 2013 recommendations, stating that it should be considered a treatment option after biologic treatment failure; however, long-term safety data are lacking and the number of infections in tofacitinib-treated patients during clinical trials is potentially concerning.24

Treatment Safety There are several safety concerns when treating patients with RA, and pharmacists play a key role in ensuring appropriate screening and monitoring. All biologic agents interfere with normal immune response, and patients should be monitored and appropriately treated for infections. In addition, patients should be educated regarding the potential for injection site or infusion-related reactions. Any patient considered for biologic therapy should be screened for latent tuberculosis infection.6 Patients should not receive live attenuated vaccines (such as herpes zoster [shingles]) during therapy with biologic DMARDs or tofacitinib.6,33 Other vaccines may be given during DMARD or biologic therapy. Patients with untreated hepatitis B or with treated hepatitis B Child-Pugh class B or higher should not be treated with any biologic agent because of risk for reactivation. Previously, biologic agents were not recommended for patients with hepatitis C; however, etanercept has been shown to be a safe option and is recommended in the most recent guidelines.6,11,37 There is conflicting information regarding the use of the TNF-α inhibitors in patients with heart failure, but they are not recommended for use in patients with New York Heart Association Class III or IV heart failure and with an ejection fraction of 50% or less.6 Postmarketing reports of lymphoma, skin cancer, and solid malignancies led to a boxed warning for TNF-α antagonist use in children and adolescents.38 Although an early meta-analysis supported an increased risk for malignancy in patients treated with TNF-α antagonists, more recent meta-analyses have not found an increased risk.39-41

Conclusion Rheumatoid arthritis is a complex autoimmune disease resulting in pain and disability for many individuals. There are now a number of treatment options to improve the disease course. Biologic agents that antagonize TNF-α, interleukins, and T-cell activation, or those that promote the destruction of B cells are all effective treatments. Few agents have been directly compared, and it is unclear if any of the agents offer a superior safety or efficacy profile. Tofacitinib is a novel treatment for RA. It has promising efficacy results; however, additional long-term

•

see RHEUMATOID, page 10

Specialty Pharmacy Continuum • Fall 2014

CLINICAL

RHEUMATOID continued from page 9

safety data are lacking. Pharmacists play an important role not only in the selection of an appropriate treatment option, but also in ensuring safe use of these agents in practice.

References 1. Rheumatoid arthritis. Centers for Disease Control and Prevention. http://www.cdc.gov/ arthritis/basics/rheumatoid.htm. Accessed November 3, 2014. 2. Helmick CG, Felson DT, Lawrence RC, et al for the National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part I. Arthritis Rheum. 2008;58(1):15-25. 3. Wahl K, Schuna AA. Rheumatoid arthritis. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey L, eds. Pharmacotherapy: A Pathophysiologic Approach. 9th ed. New York, NY: McGraw-Hill; 2014. http://accesspharmacy. mhmedical.com/content.aspx?bookid=689&Sec tionid=48811479. Accessed November 3, 2014. 4. Shah A, St Clair E. Rheumatoid arthritis. In: Longo DL, Fauci AS, Kasper DL, Hauser SL, Jameson J, Loscalzo J, eds. Harrison’s Principles of Internal Medicine. 18th ed. New York, NY: McGraw-Hill; 2012. http://accesspharmacy. mhmedical.com/content.aspx?bookid=331&Sect ionid=40727122. Accessed November 3, 2014. 5. The 2010 ACR-EULAR classification criteria for rheumatoid arthritis. American College of Rheumatology website. http://www.rheumatology.org/ACR/practice/clinical/classification/ ra/ra_2010.asp. Accessed November 3, 2014. 6. Singh JA, Furst DE, Bharat A, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of diseasemodifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res. 2012;64(5):625-639. 7.

Disease Activity Score in 28 Joints (DAS28). American College of Rheumatology website. http://www.rheumatology.org/assets/0/116/525/ 605/eaf54d09-6258-48c3-9244-58d565bfeabd. pdf. Accessed November 3, 2014.

8. 2011 RA remission criteria. American College of Rheumatology website. https://www.rheumatology.org/practice/clinical/classification/

ra/ra_remission_2011.asp. Accessed November 3, 2014. 9. American College of Rheumatology Committee to Reevaluate Improvement Criteria. A proposed revision to the ACR20: the hybrid measure of American College of Rheumatology response. Arthritis Rheum. 2007;57(2):193-202. 10. Mouterde G, Baillet A, Gaujoux-Viala C, et al. Optimizing methotrexate therapy in rheumatoid arthritis: a systematic literature review. Joint Bone Spine. 2011;78(6):587-592. 11. Saag KG, Teng GG, Patkar NM, et al. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum. 2008;59(6):762-784. 12. Clinical Pharmacology [database online]. Tampa, FL: Elsevier/Gold Standard; 2014. http:// clinicalpharmacology-ip.com/default.aspx. Accessed November 3, 2014. 13. Humira [package insert]. North Chicago, IL: AbbVie; 2014. 14. Cimzia [package insert]. Smyrna, GA: UCB; 2013. 15. Enbrel [package insert]. Thousand Oaks, CA: Amgen; 2013. 16. Simponi/Simponi Aria [package insert]. Horsham, PA: Janssen Biotech; 2014. 17. Remicade [package insert]. Horsham, PA: Janssen Biotech; 2013. 18. Orencia [package insert]. Princeton, NJ: BristolMyers Squibb; 2013. 19. Rituxan [package insert]. South San Francisco, CA: Genentech, Inc; 2014. 20. Actemra [package insert]. South San Francisco, CA: Genentech, Inc; 2013. 21. Etanercept Product Approval Information – Licensing Action 12/2/98. Food and Drug Administration website. http://www.fda.gov/ Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ ucm080536.htm. Accessed November 3, 2014. 22. Aaltonen KJ, Virkki LM, Malmivaara A, et al. Systematic review and meta-analysis of the efficacy and safety of existing TNF blocking agents in treatment of rheumatoid arthritis. PLoS One. 2012;7(1):e30275.

24. Smolen JS, Landewé R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014;73(3):492-509. 25. Kineret [package insert]. Stockholm, Sweden: Swedish Orphan Biovitrum AB; 2013. 26. Gabay C, Emery P, van Vollenhoven R, et al on behalf of the ADACTA Study Investigators. Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): a randomised, double-blind, controlled phase 4 trial. Lancet. 2013;381(9877):1541-1550. 27. Schiff M, Keiserman M, Codding C, et al. Efficacy and safety of abatacept or infliximab vs placebo in ATTEST: a phase III, multi-centre, randomised, double-blind, placebo-controlled study in patients with rheumatoid arthritis and an inadequate response to methotrexate. Ann Rheum Dis. 2008;67(8):1096-1103. 28. Weinblatt ME, Schiff M, Valente R, et al. Headto-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: findings of a phase IIIb, multinational, prospective, randomized study. Arthritis Rheum. 2013;65(1):28-38. 29. Genovese MC, Becker JC, Schiff M, et al. Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition. N Engl J Med. 2005;353(11):1114-1123. 30. Weinblatt M, Combe B, Covucci A, et al. Safety of the selective costimulation modulator abatacept in rheumatoid arthritis patients receiving background biologic and nonbiologic diseasemodifying antirheumatic drugs: a one-year randomized, placebo-controlled study. Arthritis Rheum. 2006;54(9):2807-2816. 31. Gomez-Reino JJ, Maneiro JR, Ruiz J, et al; MIRAR Study Group. Comparative effectiveness of switching to alternative tumour necrosis factor (TNF) antagonists versus switching to rituximab in patients with rheumatoid arthritis who failed previous TNF antagonists: the MIRAR Study. Ann Rheum Dis. 2012;71(11):1861-1864.

January 29, 2014]. Ann Rheum Dis. doi: 10.1136/ annrheumdis-2013-203993. 33. Xeljanz [package insert]. New York, NY: Pfizer Labs; 2014. 34. van Vollenhoven RF, Fleischmann R, Cohen S, et al for the ORAL Standard Investigators. Tofacitinib or adalimumab versus placebo in rheumatoid arthritis. N Engl J Med. 2012;367(6):508-519. 35. Lee EB, Fleischmann R, Hall S, et al for the ORAL Start Investigators. Tofacitinib versus methotrexate in rheumatoid arthritis. N Engl J Med. 2014;3370(25):2377-2386. 36. Orange Book: Approved drug products with therapeutic equivalence evaluations. US Food and Drug Administration website. http://www. accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=203214&TABLE1=OB_Rx. Accessed November 3, 2014. 37. Zein NN; Etanercept Study Group. Etanercept as an adjuvant to interferon and ribavirin in treatment-naïve patients with chronic hepatitis C virus infection: a phase 2 randomized, double-blind, placebo-controlled study. J Hepatol. 2005;42(3):315-322. 38. Information for healthcare professionals: tumor necrosis factor (TNF) blockers. US Food and Drug Administration website. http://www.fda. gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ ucm174474.htm. Accessed November 3, 2014. 39. Bongartz T, Sutton AJ, Sweeting MJ, et al. AntiTNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA. 2006;295(19):2275-2285. 40. Moulis G, Sommet A, Béné J, et al. Cancer risk α at recommended doses in adult of anti-TNF-α rheumatoid arthritis: a meta-analysis with intention to treat and per protocol analyses. PLoS One. 2012;7(11):e48991.

23. Michaud TL, Rho YH, Shamliyan T, et al. The comparative safety of TNF inhibitors in rheumatoid arthritis – a meta-analysis update of 44 randomized controlled trials [Epub ahead of

32. Emery P, Gottenberg JE, Rubbert-Roth A, et al. Rituximab versus an alternative TNF inhibitor in patients with rheumatoid arthritis who failed to respond to a single previous TNF inhibitor: SWITCH-RA, a global, observational, comparative effectiveness study [Epub ahead of print

41. Le Blay P, Mouterde G, Barnetche T, Morel J, Combe B. Risk of malignancy including nonmelanoma skin cancers with anti-tumor necrosis factor therapy in patients with rheumatoid arthritis: meta-analysis of registries and systematic review of long-term extension studies. Clin Exp Rheumatol. 2012;30(5):756-764.

10 years once biosimilars are brought to market, Dr. Castagna noted. In contrast, others estimate their entry will save $25 billion. (For a recent RAND Corporation estimate, see page 11.) The interchangeability of the products will remain an issue. Will they have the same clinical result in each patient? Will it be safe to switch from one to another? What happens if the biosimilar does not receive all the same indications as the reference product? What about off-label use? Who will be responsible if the biosimilar results in an adverse reaction? These are all questions that everyone is asking, but no one can truly answer

until after the biosimilars are available here, the panelists agreed. It will be important that all the stakeholders communicate and share their data, Ashish Dugar, PhD, MBA, the head of the External Development Group at Roche, stressed. Dr. Dugar sees three issues as key once biosimilars are on the market: education, access and communication. Manufacturers will need to explain to providers and patients why they should use a biosimilar instead of the reference product, he said. “Success will depend on providing services that meet the needs of the patients,” Dr. Dugar added. “Physicians have received mixed messages, especially concerning adverse events,” said Jodi Devlin, RN, MBA, of Therapeutic Proteins International, in Chicago, who added that physicians and pharmacists will understand the reasons for switching and so will patients if they get the right information about biosimilars. Ms. Devlin

noted that patients sorely need these products and offered one statistic to prove her point: 66% of cancer patients say they suffer a hardship because of the cost of their treatment, and 65% say they cannot focus on getting better because of the stress of that cost ((Social Work Today 2010;10[2]:14). Tim Affeldt, PharmD, the director of Specialty/Infusion Operations at Fairview Pharmacy Services LLC, in Minneapolis, pointed out that many of the issues raised about biosimilars currently are more of a concern to manufacturers than pharmacists, providers and patients. “We focus on what is going on now,” Dr. Affeldt said. “The health system will focus on it [biosimilars] after there is a product.” There is one possibility that everyone does seem to agree on: As Dr. Castagna put it, “if one biosimilar has a misstep [in the United States], it will crush the market.” —Marie Rosenthal

BIOSIMILARS continued from page 1

reference products, health care systems that are looking for the steep discounts they see when a generic drug comes on the market will be disappointed. “Biosimilars will never have generictype pricing,” said Michael Castagna, PharmD, MBA, the vice president of Lifecycle Management at Amgen, in Los Angeles. Drugs account for only 9% to 10% of total health care costs, and biosimilars, although very expensive, are an even smaller portion of those expenditures, Dr. Castagna explained. Although the savings from biosimilars are expected to be significant, the estimates are so wide and depend on so many variables that it will be tough for any pharmacy formulary decision maker to come to budgetary estimates. Express Scripts projects the United States would save about $250 billion over

print June 17, 2014]. Am J Med. doi: 10.1016/j. amjmed.2014.06.012.

Specialty Pharmacy Continuum • Fall 2014

CLINICAL ???

RAND Corporation: Biosimilars Could Save Billions

he introduction of biosimilar versions of complex biologic drugs in the United States could cut spending on biologics by an estimated $44 billion over the next decade, according to a new analysis from RAND Corporation. The calculations were based on several variables, including future use of biosimilars and the effect of increased competition and acceptance of the drugs by physicians, patients and payors. Experience with the drug class in the European Union, where biosimilars have been available for a decade, was also considered, as were U.S. sales figures for more than 100 biologics, including all blockbuster biologics with sales of more than $1 billion annually. In total, the drugs had sales of $66.3 billion in 2013 across all distribution channels. Assuming that biosimilars will penetrate 60% of the market, the researchers estimated that savings with biosimilars would be $44.2 billion over 10 years or about 4% of the total sales for biologics over that period. “However, the magnitude of savings will depend on a number of factors, including forthcoming decisions from the FDA,” said Andrew Mulcahy, the report’s lead author and a policy researcher at RAND, a nonprofit research organization. That’s why the researchers cited a range of potential savings, he noted—from a low of $13 billion to a high of $66 billion. Sandoz, a Novartis company, supported the analysis. In July, the FDA accepted the company’s biologics license application for filgrastim, which was filed under the agency’s new biosimilar pathway. The reference product, Neupogen (Amgen), is a human granulocyte colony-stimulating factor indicated to reduce infection manifested by febrile neutropenia in certain cancer patients.

Not ‘Generics’ Biosimilars are highly similar versions of branded biologic “reference” products. Because of that similarity, many people will think of biosimilars as “generic” fomulations, but the FDA’s Leah Christl, PhD, said in an interview that the term is incorrect. “Unlike generic drugs, whose structure can usually be completely defined and entirely reproduced, biologic products are typically more complex,” said Dr. Christl, the associate director for therapeutic biologics at the FDA’s Office of New Drugs. “Biosimilars and interchangeable biological products are unlikely to be shown to be structurally identical to a previously licensed biologic product.” Draft materials released by the FDA underscore that point, making it clear

ilars will require at least one head-tohead clinical trial to confirm similarity to the original biologic, a more stringent process than required for standard generics. This confirmation is not required in the European Union.

A Huge Market that not all biosimilars will be deemed interchangeable with their reference products. In addition, nearly all biosim-

As the U.S. approval pathway for biosimilars continues to play out, one factor remains clear: the huge size of

the pharmaceutical market that will be affected when biosimilars are finally passed. In 2011, eight of the top 20 drugs in this country in terms of sales were biologics, and the annual spending on the class has increased three times faster than for other prescription medications, acording to the latest industry figures. —Marie Rosenthal

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CLINICAL

INFUSION THERAPY continued from page 1

to consider, if providers have an option to treat patients with PIDD in an environment where they are not exposed to other sick patients, they should do it, said Patrick Bonnet, PharmD, Baxter’s director of health economics. The work dovetails with another recent Baxter-sponsored study demonstrating that patients with PIDD who received IVIG at home versus in an outpatient hospital incurred significantly lower costs per infusion, had significantly higher compliance with receiving infusions and had lower hospitalization and pharmacy costs. That study, published online April 15 in the American Journal of Pharmacy Benefits (2014;6:e41-e49) pulled data on 344 patients with PIDD from a large national database of Blue Cross Blue Shield participants. The adjusted mean cost per infusion was $3,293 per patient in the home setting versus $4,745 in the outpatient cohort, or 31% lower ((P<0.0001). “Such differences in direct costs between the two settings are of considerable importance to payors who must evaluate data across large numbers of patients in their membership,” the authors wrote. Based on the difference in the cost per infusion, researchers estimated that IVIG treatment delivered in the home setting could result in an annual savings of $18,876 to $26,136 for one patient receiving 13 to 18 infusions per year. Based on such results, it’s perhaps not surprising that there is a push for infusion to be done at home “as much as possible,” said Randy Fasnacht, RPh, the director of pharmacy at Advanced Infusion Services, a home infusion company owned by Akron General Hospital in Ohio. “The outcomes are better; infection rates are reduced; and costs are 20% to 40% lower. At the current time, this is the best option,” he said. Even hospitals and physicians are on board, said Russell Bodoff, the president of the National Home Infusion Association (NHIA). “We’re not saying that hospitals and outpatient clinics are not appropriate—they are for the right patient. But the physician should make that decision.” Although hospitals have worked hard to reduce hospital-based infections, the risk cannot totally be eliminated, “so if a patient doesn’t need to be in an institutional setting, there’s no reason to have them there,” Mr. Bodoff said.

CMS a Holdout Although most commercial insurers and some government payors, such as the Veterans Health Administration and state Medicaid programs, cover home infusion medications and related services, the Medicare fee-for-service

‘The outcomes [from home infusion] are better; infection rates are reduced; and costs are 20% to 40% lower. At the current time, this is the best option.’ —Randy Fasnacht, RPh

program has held out. Medications are covered by Medicare Part D, but the services, equipment and supplies—about 55% of the cost of the treatment—are not, Mr. Bodoff said. The Centers for Medicare & Medicaid Services (CMS) does fully cover infusion therapy in medical settings like hospitals, skilled nursing facilities and physician offices.

address the coverage gap (H.R. 5435). The Medicare Home Infusion Site of Care Act would allow Medicare Part B to pay for infusion-related care and services, including equipment and supplies, in a patient’s home. Nursing care and supplies would be covered under a bundled payment. The bill was jointly referred to the House Energy and Com-

‘We’re not saying that hospitals and outpatient clinics are not appropriate— they are for the right patient. But the physician should make that decision.’ —Russell Bodoff

A study from the Centers for Disease Control and Prevention in March (N ( Engl J Med 2014;370:1198-1208) found the likelihood of contracting an infection in a health care institutional setting to be one in 25, Mr. Bodoff said, and the infections can cost $30,000 to $40,000 to treat. Patients at highest risk for infection include the elderly, those with reduced immunity and those with an open wound—the very characteristics of a typical Medicare home infusion patient, he pointed out. “In many ways we are spending valuable government dollars to place Medicare patients at risk,” Mr. Bodoff said. “It’s wrong.” In September, the NHIA, through Reps. Eliot Engel (D-NY) and Pat Tiberi (R-OH), proposed new legislation to the House of Representatives to

merce Committee and the House Ways and Means Committee on Sept. 10. This is the association’s second goround with legislation. An earlier version of the bill, called the Medicare Home Infusion Therapy Coverage Act, was originally proposed in 2009 and reintroduced in 2011. It was never approved, in part because of a lack of outcomes data. But the new bill carries with it recent study results from the health policy firm Avalere indicating that Medicare could save an estimated $80 million over a 10-year period by covering home-based infusions for anti-infective therapy alone. NHIA asked Avalere to analyze the effect on Medicare program expenditures assuming a portion of patients receiving anti-infective infusion therapy from skilled nursing facilities, hos-

pital outpatient departments and physicians’ offices shifted their infusion treatment setting to the home. Under these assumptions, Avalere estimated savings to the Medicare program for the 10-year period from 2015 to 2024 of 12.6%, or $80 million, of the overall cost of infusion services. The first-year savings, assuming implementation in 2015, would be approximately 17.7%, or $8.5 million. The full report is available at www.nhia.org/Avalere. The issue previously was not that members of Congress and congressional staff felt the legislation was unimportant, Mr. Bodoff said, but it was regarded as a cost. “What has people excited now and [feeling] positive is the fact that with the Avalere study, you have an independent, well-respected group indicating that there’s significant savings.” CMS declined to be interviewed. “We can’t comment on pending legislation,” said Rachel Maisler, an agency spokesperson.

Demonstration Project Meanwhile, there is hope for some Medicare patients. At the end of the summer, the agency launched a threeyear demonstration project to study the effects of paying for administration of IVIG drugs for patients with PIDD. During the study, Medicare will cover supplies and related nursing services for up to 4,000 patients. As of press time, the agency was still enrolling applicants. Beneficiaries can find out more information or enroll at www.medicarenhic. com and click on “beneficiary.” But IVIG for patients with PIDD is generally once a month, Mr. Bodoff said, whereas a typical home infusion treatment—say, for example, antibiotics—is once or even twice a day. “While we think that some of the outcomes of the demonstration could shed some light into our industry, using the demonstration as a proxy for the whole home infusion field would be shortsighted,” he pointed out. Looking at the new models of health care, the optimal site for care delivery is the most cost-effective site that ensures quality, according to Ernest R. Anderson Jr., RPh, a pharmacy consultant in Brockton, Mass. “But within that rubric of quality is the idea of safety,” Mr. Anderson stressed. Some of the drugs being infused today are more sophisticated than basic parenteral nutrition and antibiotics, he pointed out, and patients initially should be infused in a health care setting to rule out drug reactions. “If a patient has a severe reaction to the drug, that would in a home be difficult to treat,” he said. “I would not start a new patient on a new drug in the home without knowing how they will respond to therapy.” —Karen Blum

Specialty Pharmacy Continuum • Fall 2014

OPERATIONS & MANAGEMENT

Know Your Objectives, Then Build Your Hub Ray Kinsella: ‘If you build it, he will come.’ Annie Kinsella: If you build what, who will come? Ray: He didn’t say. Annie: Ooh, I hate when that happens. —Field of Dreams, 1989 Philadelphia—“If you build it, they will come” might work for fantasy baseball fields but it is probably not a good tactic for developing a real-world medical hub. A better strategy is to have a clear game plan, according to Douglas Bock, who spoke recently at the Patient Solution Services and Hub Design meeting.

ple: The prescriber makes a diagnosis and prescribes the product. The prescription goes to the pharmacy, which handles reimbursement issues, dispenses the prescription and educates the patient. The patent takes the drug. Despite their good intentions, when companies add a hub, it adds a layer to that process. So, now: the prescriber

Table 1. Breaking Down Barriers to Access Hubs or patient service centers help improve access to therapy by addressing barriers to receiving medication. Prescriber

Pharmacy

Patient/Caregiver

• Reduce administrative burden

• Additional alternate payor research

• Reduced payor interaction

• Streamlined benefit investigation and/or prior authorization

• Link to PAP

• Barriers to access addressed by professionals

• Patient financial barriers addressed by manufacturer

• Simple adjudication of support programs

• OOP expenses addressed

• Link to PAP

• Simplified necessity

• Social support

OO , out o OOP, of poc pocket; et; PAP,, patient pat e t assistance asss sta ce programs p og a s

‘For just about every specialty pharmacy drug, I would advocate for having a hub, but I would caution you to care about the scope of the services.’ —Douglas Bock “Many times, people say, ‘we need a hub,’ but they don’t know why. What are the objectives you are trying to achieve?” said Mr. Bock, the managing director of Apogenics Inc., a medical consulting firm. Too often, companies take a brandcentric approach rather than an enduser approach when developing the hub, and that can lead to end-user frustration and delays in product distribution. A better approach is to outline the goals of the hub, determine its stakeholders and answer a need, Mr. Bock said. Foremost in the process should be the patient, according to David Caponera, the vice president of patient advocacy and reimbursement at Catalyst Pharmaceuticals. Ask what you want to do for your patients, he suggested. Pharmaceutical companies and specialty pharmacies must understand the patient’s needs and expectations. “Never get in the way of a willing prescription,” Mr. Bock said. Although hubs are important, they often add an additional layer of redundancy that frustrates patients, providers and pharmacists and delays the distribution of product, he explained. In addition, delays cost money.

Not a Database Many times the “real” purpose of the hub is to capture data, but Mr. Bock said there are simpler and less expensive ways to accomplish that goal. Think of the patient journey and create a hub that enhances and helps that journey, instead of building a fancy database, Mr. Bock suggested. For most diseases and medications, the patient medication journey is sim-

makes a diagnosis and writes a prescription. The prescription goes to the hub, which enrolls the patient, handles reimbursement issues, provides education and ships the drug to the pharmacy. The pharmacy gets the prescription, handles reimbursement issues, dispenses the prescription and educates the patient. “As soon as you add a hub, it becomes more complicated and potentially redundant,” Mr. Bock said. Hubs frequently do insurance verification, copay support, etc., and then send everything to the specialty pharmacy, which will do the same thing for free. He asked the specialty pharmacists in the audience: “How many times do you trust the reimbursement work of a hub before you dispense? Ever? Never? There is not a pharmacy that would accept the word of a hub: ‘These guys say we are going to get paid.’” Mr. Bock warned companies not to create bottlenecks that prevent patients from getting their prescription. Mr. Caponera recommended that hub developers understand the delivery and supply chain and its effects on the hub services.

Time To Fill Mr. Bock asked the audience what a reasonable “time to fill” a prescription was and when that clock starts running. The answer varied from less than two to 60 days, and the clock began with making sure reimbursement issues were settled. Not so in the patient’s mind, Mr. Bock said. “To the patient, the reason [for the wait] doesn’t matter. ‘It’s been two weeks since I’ve been to the doctor’s and I still haven’t heard anything,’” he said. “If you’ve got late-stage cancer,

Table 2. If You Build It Because there are many potential barriers to product access, there are several different types of hubs. Douglas Bock suggests you understand your hub’s purpose before designing it. Reimbursement Hubs

• Address coverage barriers • Address financial barriers

Distribution Hubs

• Address product barriers • Short supply of drug or few patients (orphan drugs)

REMS Hubs

• Address safety barriers • Ensure safe use (ETASU)

Combination Hubs

• • • •

Reimbursement Access Distribution Safe use

And potential for creating different patient experiences

ETASU, SU, Elements e e ts to Assure ssu e Safe Sa e Use

and you might only have five months to live, and it takes two weeks to get the first call—that is unacceptable.” Hubs can add a valuable service, and every specialty product should have one, but the most successful hubs have a clear mission, Mr. Bock said. “I’m not

saying hubs are bad or don’t use hubs. In fact, for just about every specialty pharmacy drug, I would advocate for having a hub, but I would caution you to care about the scope of the services,” he said. —Marie Rosenthal

FDA WATCH

Obizur Approved for Rare Hemophilia A

he FDA has approved the antihemophilic factor (recombinant), porcine sequence, Obizur (Baxter) for the treatment of bleeding episodes in adults with acquired hemophilia A, a rare but potentially life-threatening disorder. The safety and efficacy of Obizur, which was given priority review and granted orphan drug status, was evaluated in a prospective multicenter Phase II/III open-label clinical trial with 29 patients. Of the patients treated with the drug, 100% showed a positive response, meaning an effective or partially effective response with bleeding stopped or reduced and clinical improvement at 24 hours after the initial infusion. Successful treatment of the initial bleeding episode was seen in 86% of patients. The investigator defined overall treatment success as the ability to discontinue or reduce the dose and/or dosing frequency of Obizur. The most common adverse reaction, observed in more than 5% of 29 patients, was the development of inhibitors to porcine factor VIII. Obizur contains a recombinant analog of porcine factor VIII, which is used because it is sufficiently similar to human factor VIII to be effective in blood clotting, but is less susceptible to inactivation by circulating human factor VIII antibodies, according to the manufacturer.

Specialty Pharmacy Continuum • Fall 2014

OPERATIONS & MANAGEMENT

As market narrows, competitive landscape gets trickier

Finding Safe Harbors in Specialty Contracting Philadelphia—Specialty drug manufacturers are choosing to build narrower networks with fewer pharmacy providers, according to experts at the World Congress on Specialty Market Access. “Three companies—CVS Caremark [now CVS Health], Walgreens and Express Scripts—continue to hold the lead market share, with a majority of specialty pharmacy revenues,” said Michael R. Hess, Esq., a partner in Bass, Berry and Sims, whose practice focuses on pharmaceutical trade and distribution and who serves as outside counsel to many of the leading independent specialty pharmacy companies. Market consolidation has significant implications for contract relationships, noted Mr. Hess’ fellow panelist Scott Friedman, a senior vice president for specialty pharmacy, trade relations and marketing with Aureus Health Services. The trend raises, for example, the following question that needs to be posed to manufacturers: “What do you want to accomplish with your networks? What are you looking for? Is defaulting to the larger well-known entities working for you?” Mr. Friedman said. Manufacturers choose specialty distribution for a few key reasons, panelists noted. These include: • Elimination of distributor intermediary costs; • Greater control over dispensing location; • Greater adherence to therapy; • Better access to data; • Control over Risk Evaluation and Mitigation Strategy programs; • Better integration with reimburse-

ment hubs; and • Perception of higher-quality patient management. In a traditional open distribution network, the manufacturer of a drug disburses extensive inventory to a wholesale distributor like Cardinal, McKesson or AmerisourceBergen; from there, the product moves to multiple wholesalers who then distribute it through their own networks to pharmacies, hospitals and physicians. But in a limited distribution network, the manufacturer will eliminate the wholesaler and simply place the drug with a third-party logistics partner (3PLs) to do direct distribution on their behalf (Figure). “This allows for narrower inventory disbursement, fewer middlemen, more control over the quality of providers and some ability to mandate consistency through direct contracting,” Mr. Hess said. “For smaller companies, you have to go in and pick two or three players you know are going to drive the market,” said Wesley Winn, the vice president for commercial operations, market access and supply chain at Hyperion Therapeutics. “Ultimately, specialty pharmacies can’t sell for you, but in some ways they serve the same role as a dedicated hub, interacting with the customer on a daily basis.” There are three key types of contracts that pharmaceutical manufacturers negotiate with hubs, 3PLs, specialty phar-

Traditional Open Distribution Network • Extensive inventory disbursement • Numerous middle men • Limited control over quality of providers • Limited ability to mandate consistency

Figure. Drug distribution di ib i network k models. d l 3PL, third-party logistics partner; PA, patient assistance; FAP, family advocacy program

macies and specialty distributors: bona fide service fee agreements; purchase discount agreements; and performance rebate agreements. A purchase discount agreement is fairly straightforward and has fewer requirements placed on it, Mr. Hess said. “The manufacturer will sell the product, and depending on class of trade and purchase volume, they will be offered a discount,” he explained. “A performance rebate agreement is much like a purchase discount—but on the back end, based on the amount purchased. With bona fide service fees, the manufacturer is purchasing things it wants from a 3PL, hub or a specialty pharmacy—things of value like the ability to have a package closer to the customer, instead of holding all stock centrally, and services like data, call teams and the guarantee that specific people will take their call instead of being routed into the general queue with 1,500 other people.”

Staying in the ‘Safe Harbor’ These types of contracts, Mr. Hess said, must be carefully structured and managed to avoid straying from the “safe harbor” exceptions that keep pharmaceutical service agreements from running afoul of federal anti-kickback laws. “You cannot provide remuneration to any party to induce or reward the referral of federal health care program business,” he explained. “That’s anything of value to influence the decision. Taking work out of the doctor’s office, for example, he has to pull files every day to fill out prior authorization forms, and the manufacturer or the specialty pharmacy sends someone to do that so

his secretaries don’t have to. That can influence ordering patterns, and it can go in many directions. We commonly think about the manufacturer paying the specialty pharmacy for influencing a doctor, but we forget that the specialty pharmacy can also pay the manufacturer to influence the reimbursement hub to send them more referrals.” There are three primary safe harbors applicable to agreements among manufacturers, distribution and specialty pharmacy, Mr. Hess said: • The discount safe harbor. A purchase discount will not be considered a kickback as long as it is fully transparent to the ultimate payer. “This is how a manufacturer can give a 3% purchase discount while a competitor is giving 2%,” Mr. Hess said. • The personal services safe harbor. This exception is used widely throughout the industry to construct service relationships. “When a manufacturer pays a specialty pharmacy for data, that’s a service they’re providing that has fair market value,” Mr. Hess pointed out. “When appropriately structured, that means it’s not a kickback. But you need evidence of what fair market value is, and not pay more or less than the service is worth.” • The group purchasing organization (GPO) safe harbor. This, Mr. Hess said, allows a manufacturer to pay administrative fees to a GPO to negotiate discounts on behalf of multiple buyers or to pharmacy benefit managers (PBMs) to negotiate rebates for many payors, allowing PBMs to aggregate clients and receive administrative fees.

Typical Limited Distribution Network • Narrow inventory disbursement • Fewer middle men • More control over quality of providers • Some ability to mandate consistency through direct contracting

Specialty Pharmacy Continuum • Fall 2014

OPERATIONS ??? & MANAGEMENT

Mr. Hess used several recent cases to highlight what can happen when players in the specialty pharmacy space run afoul of these nuances of fraud and abuse laws—and how these nuances may be evolving to put previously acceptable practices on the wrong side of the line. Last November, Johnson & Johnson (J&J) and its subsidiaries agreed to pay more than $2.2 billion in a settlement with the Department of Justice (DOJ) involving multiple charges, including allegations that J&J and Janssen paid kickbacks to Omnicare Inc., the nation’s largest pharmacy specializing in dispensing drugs to nursing home patients. The DOJ alleged that J&J paid millions of dollars in kickbacks to Omnicare under the guise of market share rebate payments, data-purchase agreements, grants and educational funding. “Omnicare’s consultant pharmacists regularly reviewed nursing home patients’ medical charts and made recommendations to physicians on what drugs should be prescribed for those patients,” said a DOJ release. “Although consultant pharmacists purported to provide ‘independent’ recommendations based on their clinical judgment, J&J viewed the pharmacists as an ‘extension of [J&J’s] sales force.’” Mr. Hess warned: “When you are in discussions with specialty pharmacy partners or manufacturers, never use language that infers that you can switch patients. That’s not what you do as a pharmacy, you can’t get paid for it, and you shouldn’t create email trails that suggest you can.” He noted that J&J/ Janssen tried to claim the bona fide service fee safe harbor, saying that they were paying Omnicare for data, but Omnicare could not prove they delivered the data in question.

Amgen: A Cautionary Tale In April 2013, Amgen paid nearly $25 million to settle allegations that it used kickbacks to induce long-term care pharmacies’ use of darbepoetin alfa (Aranesp), giving rebates to the pharmacies for boosting Amgen’s market share and for hitting certain volume targets. The DOJ alleged that Omnicare, PharMerica and Kindred Healthcare were paid by Amgen to identify Medicare and Medicaid patients using the J&J rival drug epoetin alfa (Procrit), and switch them to Aranesp instead. But what about that anti-kickback safe harbor for purchase discounts? Didn’t Amgen meet that? “The Department of Justice said that ‘market share’ was a payment to incentivize switching of patients from one product to another,” Mr. Hess explained. “We’re seeing a big trend to pull back from certain types of market share rebate agreements.” Another prosecution, still ongoing at press time, calls into question the use

of adherence rebates. “A few years ago, Novartis recognized that it was having issues with adherence on its Exjade [deferasirox] product,” Mr. Hess said. (Exjade is an iron chelation therapy indicated for chronic iron overload due to blood transfusions, commonly used in anemia patients.) “Patients may become noncompliant due to side effects at certain points in the treatment cycle,” Mr. Hess said. “Novartis provides service fees and preferred rotations from the reimbursement hub for specialty pharmacies with

the highest adherence rate or with the best results in helping patients manage through side-effect issues and keep patients on therapy. Now, we as specialty pharmacies believe that adherence is fundamental. But the attorney general for the southern district of New York saw this as paying pharmacies to manipulate physicians and patients.” So yesterday’s seemingly legitimate contract element may be tomorrow’s illegal kickback. “Know what you’re contracting for,” Mr. Hess warned. “Make sure you’re getting very clear

metrics on all of the elements you’re offering or purchasing. Make sure you can deliver and measure it, and if you say you’re going to deliver something, you’d better do it.” —Gina Shaw Mr. Friedman and Mr. Winn reported no relevant disclosures. Mr. Hess reported that he represents a number of specialty pharmacies and manufacturers as they contract for discounts, rebates or bona ﬁde service fees. He declined to speciﬁcally identify those clients, citing attorney–client privilege restrictions.

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Specialty Pharmacy Continuum • Fall 2014

OPERATIONS & MANAGEMENT

Making the case for SP’s value:

Getting Out of the ‘Evidence-Free Zone’ Tampa, Fla.—Speaking at the Pharmaceutical Care Management Association’s 2014 business forum, former Secretary of State Hillary Rodham Clinton referred to the “evidence-free zone” on Capitol Hill—where politicians offer no evidence in support of their claims, but insist they should be believed anyway. In a panel at the Academy of ManM aged Care Pharmacy’s (AMCP) 20 014 annual meeting a few weeks lateer, Karen Geary, RPh, the director off specialty pharmacy programs for MedImpact, warned that specialty pharmacy teeters on the edge of a similar label. “This will be our story if we don’t supply the evidence that we’re making a difference,” she said. “We have to be able to pull togetheer information that shows that it does make a difference to use a specialty pharmacy.”

sclerosis (MS), inflammatory conditions and HIV. Working with their client United Healthcare (UHC), OptumRx found that there was a total cost savings in each category, with oncology being the highest at $13,091 saved per patient

‘I’ve probably been to 90 of the 100 top payors, and I can’t tell you how many times they were prior-authorizing Remicade [Janssen Biotech], but the denial rate was virtually zero.’ —Kjel Johnson All of the speakers at the AMCP session on communicating the value of specialty pharmacy services agreed that there is still a paucity of data to help achieve that goal. “We need to start assembling an evidence base: What systems approaches work? What adherence programs? What measures work for the one who’s writing the check—the payor?” said Sean Sullivan, PhD, a professor of pharmacy and health services at the University of Washington, in Seattle. “We need to get away from approximations based on claims, and document the real costs and benefits of [strategies such as] intensive adherence programs.” OptumRx, a subsidiary of United Health Group and one of the largest pharmacy benefit managers (PBMs) in the country, has been working with clients to demonstrate the value of specialty pharmacy, according to Brett Sahli, PharmD, the manager of specialty pharmacy for OptumRx. “We looked at our program from a financial and utilization perspective, comparing members who used our Designated Specialty Pharmacy program to those that did not,” he said. The data, from 2007 through 2010, included five disease states that together make up about two-thirds of the specialty spend: oncology, transplant, multiple

in the first year of the program and $5,423 average annual savings over the second through fourth years. Specialty pharmacy yielded a $3,576 per-patient savings for transplant in the first year and $3,446 on average in the following years; $686 in the first year and $1,395 in subsequent years for MS; $805 and $779 for inflammatory conditions; and $14 and $531 for HIV. Drug costs increased due to improved adherence, which muted some of the savings. In the first year the program was implemented, oncology per-patient costs on the pharmacy side actually increased by $2,349, although that was offset by more than $15,000 in savings on the medical benefit side. Separately, OptumRx and UHC also evaluated utilization management (UM) programs as a variable, and compared category costs for groups that had UM implemented versus those that did not. “We found that utilization management drives considerable savings across high-cost categories,” Dr. Sahli said. The largest dollar savings came from MS and inflammatory conditions, well-known drivers of so much of specialty spending. But UM yielded the highest percentage reduction in the growth hormone category, with a 60% overall reduction in costs for 2012.

‘We have to be able to pull together information that shows that it does make a difference to use a specialty pharmacy.’ —Karen Geary, RPh

“W With multiple layers of managemeent in place, you can achieve incremental savings with each strategy,” m Dr. Sahli said. Overall, OptumRx D aand UHC have found that the speccialty pharmacy program yields aan average of $5.91 saved per em mployee per month—$3.70 from UM M, $1.79 from improved outcomes and aadherence and $0.42 from other speciialty pharmacy initiatives. The data, he pointed out, underscore the d fact that “adherence alone won’t drive all the savings, especially in the short term, when increased drug costs can mitigate what you’ve saved.”

Innovation a Cost-Saver In this age of data availability, Dr. Sahli said, specialty pharmacies should be thinking of new ways to identify patient medication management opportunities and interventions. “If we can use feeds from an integrated platform—medical data, claims data, along with pharmacy benefit claims data—we can have an approach that identifies opportunities as they’re happening and flag them for the pharmacist.” IMS Health’s Kjel Johnson raised the provocative notion that much of what specialty pharmacy (and payors and PBMs) has been focusing on to provide value, and to demonstrate that they’re doing it, could be wrong. “Formulary management? I’ve probably been to 90 of the 100 top payors, and I can’t tell you how many times they were priorauthorizing Remicade [Janssen Biotech], but the denial rate was virtually zero,” he said. “Now, it’s a great drug, but not always the most cost-effective one, and it’s often used off-label. Prior authorization isn’t just a box you check. For most prior authorizations, if you don’t have a denial rate of 10% to 15%, you’re doing it wrong.” Mr. Johnson focused on site of service as another misunderstood target for savings. “There are a couple of things driving the shift [of patient care] to hospitals,” Mr. Johnson said. “You’re paying too low. Doctors are pushing the drug out, and hospitals are dragging it in, because they bought practices and want to create an ACO [accountable

care organization], and oh, they’re buying drugs for half what everybody else is under 340B.” Instead, Mr. Johnson said, formulary management should be done through reimbursement. “Don’t tell a doctor which drug to use; tell them how you’re going to pay them,” he said. Maintaining the right site of service is something best done through improved reimbursement, he suggested. “Pay doctors a lot to use high-quality, lowcost alternatives, and you’ll keep care out of the hospital as well.” Patients can also be involved. Mr. Johnson cited cancer chemotherapy as a rich target for patient education about site of service. “For each cycle, they’re getting five or six drugs—a couple of chemos, side-effect management drugs, fluids—times an average of $141 per drug, that’s a lot per cycle. If you inform the patient of [his or her] choices, you’d be surprised—do they want to drive to downtown Boston, find parking at the hospital and sit in a room with sick people? No. Educate them, and they’ll take a hard stance that they don’t want to pay five times as much to go to the hospital for their chemo.” But whatever they do, the speakers agreed, specialty pharmacies need to do a much better job of demonstrating that the strategies work. The 9th edition of the “EMD Serono Specialty Digest” (http:// bit.ly/1qmc8H1) indicates that although more than twothirds of specialty pharmacies say they provide an adherence program, “only 60% provide adherence measurement as part of the program,” Mr. Sullivan said. Of the health plans that used the adherence program, “only 44% were satisfied with the programs and adherence measurement. “It’s time to get to the business of understanding what does and doesn’t work, and how we’re spending our money on these programs.” —Gina Shaw Ms. Geary received an honorarium from Xcenda for serving on a speakers’ bureau. Dr. Sahli owns stock in United Health Group. Mr. Johnson and Dr. Sullivan reported no ﬁnancial relationships with any commercial interests during the past 12 months.

FAST-ACTING & LONG-LASTING

Betamethasone Sodium Phosphate & Betamethasone Acetate* Injectable Suspension, USP

Patients don’t need to wait hours for relief from inflammation

Product Name

Fast-Acting

Betamethasone Sodium Phosphate p & Betamethasone Acetate* Injectable Suspension, USP

Kenalog®

(Triamcinolone Acetonide) Injectable Suspension, USP

Depo-Medrol®

(Methylprednisolone Acetate Injectable Suspension, USP)

Long-Lasting

3 3 3

Kenalog® is a registered trademark of Bristol-Myers Squibb. Depo-Medrol® is a registered trademark of Pfizer Inc.

*Betamethasone 6 mg/mL as 3 mg/mL Betamethasone Sodium Phosphate and 3 mg/mL Betamethasone Acetate The intra-articular or soft tissue administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis. Important Safety Information: Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been reported with and without use of fluoroscopy. The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use. As with any potent corticosteroid, adverse events have been associated with Betamethasone Sodium Phosphate and Betamethasone Acetate, Injectable Suspension, USP including fluid and electrolyte disturbances, as well as adverse reactions involving the following systems: allergic reactions, cardiovascular, dermatologic, endocrine, gastrointestinal, metabolic, musculoskeletal, neurological/ psychiatric, ophthalmic and other. Corticosteroids may also affect immune response. Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy. Betamethasone Sodium Phosphate and Betamethasone Acetate, Injectable Suspension, USP should not be administered intravenously or used in systemic fungal infections. Vaccination administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision, to advise any medical attendants that they are taking corticosteroids and to seek medical advice at once should they develop fever or other signs of infections. Persons who are on corticosteroids should be warned to avoid exposure to chicken pox or measles and to seek medical advice without delay if exposed. Please see next page for Brief Summary of Full Prescribing Information

www.DualAgentBeta.com ®

BB036 Rev. 10/2014

One Luitpold Drive - PO Box 9001 - Shirley, NY 11967 | 800-645-1706

Betamethasone Sodium Phosphate and Betamethasone Acetate

Injectable Suspension, USP

6 mg per mL

Rx only DESCRIPTION Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP is a sterile aqueous suspension containing betamethasone 3 mg per milliliter as betamethasone sodium phosphate, and betamethasone acetate 3 mg per milliliter. Inactive ingredients per mL: dibasic sodium phosphate 7.1 mg; monobasic sodium phosphate 3.4 mg; edetate disodium 0.1 mg; and benzalkonium chloride 0.2 mg as a preservative. The pH is adjusted to between 6.8 and 7.2. INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as follows: Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders Congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency. Synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance. Gastrointestinal Diseases To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic Disorders Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic Diseases For palliative management of leukemias and lymphomas. Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory Diseases Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. The intra-articular or soft tissue administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis. The intralesional administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis), and psoriatic plaques; necrobiosis lipoidica diabeticorum. Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, may also be useful in cystic tumors of an aponeurosis or tendon (ganglia). CONTRAINDICATIONS Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is contraindicated in patients who are hypersensitive to any components of this product. Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura. WARNINGS Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension should not be administered intravenously. Serious Neurologic Adverse Reactions with Epidural Administration Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been reported with and without use of fluoroscopy. The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use. General Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy. In patients on corticosteroid therapy subjected to any unusual stress, hydrocortisone or cortisone is the drug of choice as a supplement during and after the event. Cardio-renal Average and large doses of corticosteroids can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients. Endocrine Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage. Infections General Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan, or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents. These infections may be mild to severe. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. Corticosteroids may also mask some signs of current infection. Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS, Drug Interactions, Amphotericin B Injection and Potassium-Depleting Agents section). Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, and Toxoplasma. It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or in any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should not be used in cerebral malaria. Tuberculosis The use of corticosteroids in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis. Vaccination Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines cannot be predicted Viral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. If exposed to chickenpox, prophylaxis with varicella zosterr immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chicken pox develops, treatment with antiviral agents should be considered. Neurologic Reports of severe medical events have been associated with the intrathecal route of administration (see ADVERSE REACTIONS, Gastrointestinal and Neurologic/ Psychiatric sections). High doses of corticosteroids, including Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, should not be used for the treatment of traumatic brain injury. Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex. PRECAUTIONS General This product, like many other steroid formulations, is sensitive to heat. Therefore, it should not be autoclaved when it is desirable to sterilize the exterior of the vial. The lowest possible dose of corticosteroid should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual. Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used. Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement. Cardio-renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency. Endocrine Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy. Therefore, in any situation of stress occurring during that period, naturally occurring glucocorticoids (hydrocortisone cortisone), which also have salt-retaining properties, rather than betamethasone, are the appropriate choices as replacement therapy in adrenocorticoal deficiency states. Gastrointestinal Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving corticosteroids may be minimal or absent. There is an enhanced effect of corticosteroids in patients with cirrhosis. Intra-Articular and Soft Tissue Administration Intra-articular injected corticosteroids may be systematically absorbed. Appropriate examination of any joint fluid present is necessary to exclude a septic process. A marked increase in pain accompanied by local swelling, further restriction of joint motion, fever, and malaise are suggestive of septic arthritis. If this complication occurs and the diagnosis of sepsis is confirmed, appropriate antimicrobial therapy should be instituted. Injection of a steroid into an infected site is to be avoided. Local injection of a steroid into a previously injected joint is not usually recommended. Corticosteroid injection into unstable joints is generally not recommended. Intra-articular injection may result in damage to joint tissues (see ADVERSE REACTIONS, Musculoskeletal section).

Musculoskeletal Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation (ie, decreasing absorption and increasing excretion) and inhibition of osteoblast function. This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age. Special consideration should be given to patients at increased risk of osteoporosis (ie, postmenopausal women) before initiating corticosteroid therapy. Neuro-psychiatric Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that they affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect (see DOSAGE AND ADMINISTRATION). An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (eg, myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular blocking drugs (eg, pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevation of creatinine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years. Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids. Ophthalmic Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored. Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision, to advise any medical attendants that they are taking corticosteroids and to seek medical advice at once should they develop fever or other signs of infection. Persons who are on corticosteroids should be warned to avoid exposure to chicken pox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay. Drug Interactions Aminoglutethimide Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression. Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (ie, amphotericin-B, diuretics), patients should be observed closely for development of hypokalemia. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure. Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance. Anticholinesterases Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. Anticoagulants, Oral Coadministration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect. Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required. Antitubercular Drugs Serum concentrations of isoniazid may be decreased. Cholestyramine Cholestyramine may increase the clearance of corticosteroids. Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use. Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia. Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect. Hepatic Enzyme Inducers (eg, barbiturates, phenytoin, carbamazepine, rifampin) Drugs which induce hepatic microsomal drug-metabolizing enzyme activity may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to an increased riskk of corticosteroid side effects. Nonsteroidal Anti-inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids. Skin Tests Corticosteroids may suppress reactions to skin tests. Vaccines Patients on prolonged corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Route administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS, Infections, Vaccination section). Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis or mutagenesis. Steroids may increase or decrease motility and number of spermatozoa in some patients. Pregnancy Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. Nursing Mothers Systematically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when corticosteroids are administered to a nursing woman. Pediatric Use The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (>2 years of age), and aggressive lymphomas and leukemias (>1 month of age). Other indications for pediatric use of corticosteroids, eg, severe asthma and wheezing, are based on adequate and wellcontrolled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations. The adverse effects of corticosteroids in pediatric patients are similar to those in adults (see ADVERSE REACTIONS). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systematically administered corticosteroids, may experience a decrease in their growth velocity. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of HPA axis suppression (ie, cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose. Geriatric Use No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and young patients, but greater sensitivity of some older individuals cannot be ruled out. ADVERSE REACTIONS (listed alphabetically, under each subsection) Allergic Reactions Anaphylactoid reaction, anaphylaxis, angioedema. Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS), pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis. Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria. Endocrine Decreased carbohydrate and glucose tolerance, development of cushingoid state, glucosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), suppression of growth in pediatric patients. Fluid and Electrolyte Disturbances Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention. Gastrointestinal Abdominal distention, bowel/bladder dysfunction (after intrathecal administration), elevation in serum liver enzyme levels (usually reversible upon discontinuation), hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis. Metabolic Negative nitrogen balance due to protein catabolism. Musculoskeletal Aseptic necrosis of femoral and humeral heads, calcinosis (following intra-articular or intralesional use), Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare (following intra-articular use), steroid myopathy, tendon rupture, vertebral compression fractures. Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo. Arachnoiditis, meningitis, paraparesis/paraplegia, and sensory disturbances have occurred after intrathecal administration (see WARNINGS, Neurologic section). Ophthalmic Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, rare instances of blindness associated with periocular injections. Other Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, weight gain. OVERDOSAGE Treatment of acute overdose is by supportive and symptomatic therapy. For chronic overdosage in the face of severe disease requiring continuous steroid therapy, the dosage of the corticosteroid may be reduced only temporarily, or alternate day treatment may be introduced. DOSAGE AND ADMINISTRATION Benzyl alcohol as a preservative has been associated with a fatal “Gasping Syndrome” in premature infants and infants of low birth weight. Solutions used for further dilution of this product should be preservative-free when used in the neonate, especially the premature infant. The initial dosage of parenterally administered Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension may vary from 0.25 to 9.0 mg per day depending on the specific disease entity being treated. However, in certain overwhelming, acute, life-threatening situations, administrations in dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages. It Should Be Emphasized That Dosage Requirements Are Variable and Must Be Individualized on the Basis of the Disease Under Treatment and the Response of the Patient. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly. ®

SEE FULL PRESCRIBING INFORMATION FOR FULL DOSAGE AND ADMINISTRATION DIRECTIONS. BS1019

Revised July 2014

Specialty Pharmacy Continuum • Fall 2014

POLICY ???

CHEMO PARITY continued from page 1

today, Mr. Farber explained at the ACCC’s Oncology Reimbursement Meeting, held in October. “We have gotten to a point where bipartisan is more or less out the window,” he said. “It has just gotten so bad. The two sides will not work together.” One bill that actually had bipartisan support was the Cancer Drug Coverage Parity Act (H.R. 1801/S. 1879), which would require private health insurers that offer IV chemotherapy benefits to patients with cancer to provide parity benefits for oral and self-injected anticancer drugs, increasing patient access to these medications. Oral and self-injected cancer medications can provide clinical advantages over more traditional cancer agents, and in some cases are “the only or the best treatment option” for a particular patient, Clifford Hudis, MD, FACP, who was the president of the American Society of Clinical Oncology (ASCO) at the time, explained in a 2013 letter to U.S. Rep. Brian Higgins (D-NY), one of the sponsors of the House bill. Professional cancer associations, such as the ACCC, ASCO and the Hematology/Oncology Pharmacy Association, as well as many patient cancer support and advocacy groups, have supported these bills, which also had “decent support” among legislators, according to Mr. Farber, who provided a legislative update at the ACCC meeting. Although federal efforts to approve oral chemo parity legislation have failed, local efforts have been very successful. “On the state level, there has been a lot more success in getting these laws passed,” he said. “There have been 30 states plus the District of Columbia that have passed oral [drug] parity legislation.”

Sequestering Sequester Cuts Another cancer drug bill, the Cancer Patient Protection Act (H.R. 1416), also was not passed this year. This bill would have exempted physicianadministered cancer drugs, mostly at clinics, from sequester cuts, according to Mr. Farber. Sequestration is automatic, broad spending cuts that Congress imposed in 2011 after the Debt “Super Committee” failed to find enough spending cuts to reduce the national deficit by $1.2 trillion. One of the results of the sequester was that the Centers for Medicare & Medicaid Services reduced reimbursements by 2% starting April 1, 2013. These are across-the-board payment reductions that affect cancer medications. “We have been working on a bill that was introduced this year, H.R. 1416, which would exempt cancer drugs from the sequester cuts,” Mr. Farber

Oral Chemotherapy Access Legislative Landscape (October 2014) 30 states have enacted oral chemotherapy access laws

RI CT

AK HI

Active campaign Signed into law

explained. “We think pulling the drugs out is especially important because we have no say as providers in how much they cost, and it is really unfair to have a penalty on providers for something they have no control over.” He said the Cancer Patient Protection Act garnered a lot of backers, with more than 100 members of Congress supporting it from both sides of the aisle, which is rare in Congress these days. However, there was no Senate companion bill, so it did not pass.

Grassroots Activity A new group formed this year, the Patient Access to Community Treatment (PACT) Coalition, to re-engage and re-energize Congress to roll back the sequester cuts. PACT met on Capitol Hill in September to bring the importance of preserving patient access to community care to the attention of legislators. Stakeholders discussed the financial and quality-of-life benefits of community care, as well as federal policies that have contributed to recent closures and consolidation of many community oncology practices. Sequester cuts were on the agenda. “We must act now to address the growing crisis facing community-based care,” said Brad Tallamy, the director of PACT, citing data showing that since 2008, more than 1,300 community can-

cer centers have closed, consolidated with hospitals, merged or reported financial problems. Furthermore, 63% of small practices report they are likely to merge, sell or close operations in the next year. In addition to the Cancer Patient Protection Act, PACT is supporting potential legislative corrections, such as H.R. 800 and S. 806, which would exclude customary promptpay discounts from Medicare Part B reimbursement formulas. According to the group, these legislative efforts are important steps toward stabilizing provider reimbursement, which could enable them to stay in business.

SGR Cuts in the Crosshairs Another sore point for oncologists— and all other physicians—is the sustainable growth rate (SGR), which is a complex formula that Medicare uses to set provider reimbursements, which are tied to the gross domestic product (GDP). “Over the last six or seven years, the formula would call for significant reductions in Medicare payments to physicians,” Mr. Farber said. Every year, Congress has stopped these reductions with short-term legislative fixes. These annual fixes have cost well over $138 billion, according to Mr. Farber. This year was the best shot that physicians had to permanently overturn the

SGR. A new plan to replace the formula would have stabilized payments and tied reimbursement to quality measures that supported innovation, and it would have cost far less than all the short-term fixes taken together. “This year, we had a cheap price tag, bipartisanship—both houses and people from both parties supported the bill—but at the end of the day, they still had a short-term patch,” Mr. Farber explained. Congress could not come up with a method to fund the new bill, so it died despite its widespread support, and because it is the end of the year, Mr. Farber does not anticipate passage of any of the health care bills. “Nothing health care–related is going to pass [this year],” Mr. Farber said. In fact, “it is very unlikely that any health care issues will come up” during the lame duck session. Next year, however, with a new Congress convening, it is possible that many of these issues and related legislation will resurface. If any health-care bills are in fact reintroduced, he noted, it will be important for health care workers to contact their legislators and offer their views on the key provisions. If lawmakers don’t hear about the consequences of these regulations, they won’t change them, Mr. Farber warned. —Marie Rosenthal

Specialty Pharmacy Continuum • Fall 2014

TECHNOLOGY ???

Real-time benefits verification far from a seamless process

e-Prior Authorization Still Hitting Snags In a world where you can use your iPad to program your DVR at home in Cleveland from your vacation cabana in Kauai, or instantly deposit a check by taking a picture with your phone, you would expect that prior authorizations and benefit verifications should be an equally smooth, seamless electronic process. Not quite. A study published in 2013 by researchers from the Office of the National Coordinator for Health Information Technology ((Am J Manag Care 2013;19[9]:760-764) found that virtually all pharmacies nationwide (94%) are accepting e-prescriptions, and more than half (54%) of health care providers are e-prescribing—percentages that have no doubt increased in the nearly two years since the data were gathered.

There has been tremendous progress on e-prior authorization (e-PA) just in the past year, according to Matt Scantland, co-founder of the most dominant e-PA company to date, the Ohio-based CoverMyMeds. “Already, we are live with PBMs [pharmacy benefit managers] that represent 72% of U.S. prescription volume; because we represent [more than] 20% of the overall PA volume in the country, true e-PA using the NCPDP [National Council for Prescrip-

‘If e-prescribing worked the way it’s supposed to, it would help avoid the majority of prior authorizations, but right now that’s not happening.’ —David Scaglione, MSM, PMC

The iAssist system accesses a patient’s insurance coverage and identifies manufacturers’ free drug and copay assistance programs.

tion Drug Programs] standard is already a big part of the world today.” But the process remains far from smooth, said David Scaglione, MSM, PMC, a senior product manager of provider connectivity with Prime Therapeutics. “E-prescribing, e-PA and benefit verification should be seamless; the doctor should send what [he or she] needs to the pharmacist and both should have full visibility for everything—but that’s not the case,” Mr. Scaglione said. “The pharmacist has all the pricing, but little medical information, and the doctor has all the medical and allergy information, but little to no pricing. There’s a wall.” Most doctors don’t rely on or trust the information they see in their systems today, he added. “If you show a doctor an alternative to a prior authorization, they’re going to prescribe it. In fact, 90% of our prior authorizations start at a pharmacy after a rejection, which puts the patient right in the middle, where they shouldn’t have to be. And 30% of patients don’t take their medications because of prior authorizations and other types of utilization management. If e-prescribing worked the way it’s supposed to, it would help avoid the majority of prior authorizations, but right now that’s not happening.” Prime Therapeutics is currently engaged in a contract research project that involves interviewing and shadowing large physician groups in an attempt to better understand their workflow and how payors and PBMs can better integrate into that process. “We now have about 20% of our PAs coming in electronically, up dramatically from just 1% to 2% a year ago.” (Prime works with CoverMyMeds for its e-PA process.) But simply increasing e-PAs isn’t the entire story. “We work with hundreds of different EMRs [electronic medical records], and you have to hope that each EMR is displaying the information accurately,” Mr. Scaglione said. “I want control over the message. I want to make sure that what I send out is displayed in a way that makes sense on the other end. Like a preferred drug: For some plans, tier 1 is the preferred drug, tier 2 and tier 3 are secondary. But for other plans, it’s the reverse. How do you think a doctor’s going to understand that? As payors and pharmacy benefit managers, we have to think a lot more like the doctors and the pharmacists.” Another major, related barrier is formulary data. “This data is sometimes inaccurate, missing or not displayed. Due to the quality of the data, doctors have a tendency to ignore it. This means that the prescription will make its way to the

CoverMyMeds software helps pharmacies check prior authorization.

‘Formulary data is one of the barriers to solving this problem, but inadequate information about limited pharmacy networks also makes e-prescribing difficult.’ —Matt Scantland pharmacy where it is rejected, rather than being initiated prospectively while the doctor is e-prescribing,” Mr. Scantland said. “CoverMyMeds can push these PAs back into the EHR [electronic health record], getting them on the e-PA track, but it would be less disruptive to everyone if it happened up front as it does when formulary data is accurate.” Specialty has its own unique challenges when it comes to e-PA—particularly slower adoption of e-prescribing. “E-prescribing is not used for most specialty prescriptions,” Mr. Scantland said. “Formulary data is one of the barriers to solving this problem, but inadequate information about limited pharmacy networks also makes e-prescribing difficult.”

Built for Specialty Pharmacy One of the few technology solutions companies in this space focused solely on the specialty marketplace is AssistRX, which in January 2014 announced a partnership with health information network behemoth SureScripts. Its iAssist platform provides instant access to e-PAs, signatures, patient consent

Specialty Pharmacy Continuum â&#x20AC;˘ Fall 2014

TECHNOLOGY

and eligibility informationâ&#x20AC;&#x201D;from any location at any time, according to Edward Hensley, the chief brand and business development officer for AssistRX. â&#x20AC;&#x153;Weâ&#x20AC;&#x2122;re currently contracted with about 32 different products,â&#x20AC;? Mr. Hensley said. â&#x20AC;&#x153;Weâ&#x20AC;&#x2122;re agnosticâ&#x20AC;&#x201D;we donâ&#x20AC;&#x2122;t play the exclusivity game. With MS [multiple sclerosis] drugs, for example, there are seven main products in the class. Doctors donâ&#x20AC;&#x2122;t want to go to seven different portals depending on the drug.â&#x20AC;? The iAssist system accesses the patientâ&#x20AC;&#x2122;s insurance coverage and identifies any opportunities to access manufacturer free drug programs and copay assistance programs. â&#x20AC;&#x153;Our information goes to several different places, depending on the brand,â&#x20AC;? Mr. Hensley said. â&#x20AC;&#x153;When the physician hits submit on the prescription, the PA request goes to the payor, but also to the hub and the specialty pharmacist so they can see that thatâ&#x20AC;&#x2122;s been done, and start all their pieces of the process. It connects all the different components that every stakeholder needs in the specialty process, and delivers it in a package with a bow on it.â&#x20AC;? So, does e-PA improve classic specialty pharmacy challenges like abandonment and adherence? CoverMyMeds is not specialty-specific, but Mr. Scantland said the improvements should be generalizable. â&#x20AC;&#x153;After a claim rejection in the pharmacy, prescription abandonment rates are between 40% and 70%,â&#x20AC;? he noted. â&#x20AC;&#x153;But when the e-PA process is available and used by the provider, the abandonment rate goes much lowerâ&#x20AC;&#x201D;basically 5% to 10% due to copay sensitivity.â&#x20AC;? At iAssist, the data are still coming in, but Mr. Hensley said it looked encouraging so far. â&#x20AC;&#x153;Weâ&#x20AC;&#x2122;ve done head-to-heads with in-house hubs for manufacturers that have piloted our services. They were at an average of seven to 14 days to get a patient on therapy, and we got it down to one to three days,â&#x20AC;? he said. â&#x20AC;&#x153;Weâ&#x20AC;&#x2122;re just starting to scratch the surface with data on abandonment, and we donâ&#x20AC;&#x2122;t yet have the data on adherence, but itâ&#x20AC;&#x2122;s going to be a huge focus for us going forward. I recently read an article that said starting next year, about 40% of a brandâ&#x20AC;&#x2122;s budget will be adherence. The classes are already so crowded that

â&#x20AC;&#x2DC;Weâ&#x20AC;&#x2122;re just starting to scratch the surface with data on abandonment, and we donâ&#x20AC;&#x2122;t yet have the data on adherence, but itâ&#x20AC;&#x2122;s going to be a huge focus for us going forward.â&#x20AC;&#x2122; â&#x20AC;&#x201D;Edward Hensley retaining patients will be the key.â&#x20AC;? The goal of all of this technology, Mr. Scaglione said, is to get the member out

of the middle. â&#x20AC;&#x153;Right now, the EMR is just a dumping ground for paper. It needs to be a full decision-support sys-

The National Association of Specialty Pharmacy (NASP) provides a forum for networking among health care professionals and all specialty pharmacy stakeholders to enhance collaboration, improve patient care and create career advancement opportunities.

tem. If a PA is going to expire, it should let you know 90 days in advance so that you can do the prework and let the system handle it. You donâ&#x20AC;&#x2122;t want the member to even know anything is happening unless thereâ&#x20AC;&#x2122;s an exception. Right now, I donâ&#x20AC;&#x2122;t think providers trust technology to let that happen, but Iâ&#x20AC;&#x2122;m optimistic that over the next few years we can do much better.â&#x20AC;? â&#x20AC;&#x201D;Gina Shaw None of the individuals interviewed reported any relevant disclosures.

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Specialty Pharmacy Continuum • Fall 2014

TECHNOLOGY

Q&A: Mark Cullen, CEO, mscripts

Drug Adherence for the Digital Age The explosive growth of cell phones and other mobile technology has been a boon to mscripts. The San Francisco-based provider of mobile applications for pharmacies has developed a wide range of textMark Cullen based reminders and other digital tools that help patients become more engaged in their own drug therapy regimens. Pharmacy Practice News recently spoke with mscripts CEO Mark Cullen for his views on the many benefits that patients and pharmacies can expect from using the company’s communication tools. PPN: Since its launch in 2008, mscripts has been using text messaging as its primary tool for promoting drug compliance. Why is that the case? Mr. Cullen: At the very beginning, I had a sense that this was going to be the easiest and simplest way to reach patients with our core refill and adherence reminders. But it really hit home after I did a bit of off-the-cuff research in a Sprint store, where I asked a technician what the average teenage customer was doing in terms of text messages per month. I figured it would be 200, maybe 300 texts. Well, it was more like 2,500 to 3,000. That really helped me understand the potential of this technology. We knew that if we could figure out a way to make text messaging work in a HIPAA-compliant manner—and we did solve that, of course—we would have a very powerful tool for promoting adherence. PPN: There are a lot of players in the mobile compliance market today. What is unique about mscripts? Mr. Cullen: One important distinguishing feature is that we are not just focused on refills and reminders, and we don’t rely only on texting to reach the patient. Rather, what we offer is a comprehensive mobile pharmacy and digital patient engagement platform. That means reaching patients with the right content, in the right format, based on their particular needs and preferences. For some individuals, texting is the best tool. But for others, a digital app for their smartphones, which we now also offer, is a better fit because it gives them the ability to track much more than prescription adherence. They can track family members’ medications, for example. We also have Web browser applications for patients who prefer that medium. It’s basical-

ly an any-screen-anywhere, anytime approach to getting patients connected to their pharmacy and pharmacist. But we knew early on that to make all of those features truly effective, and to make the information we push out to patients as relevant and convenient to access as possible, we had to become highly integrated with the back end of major pharmacy systems and dispensing platforms. We’ve made great strides in that area, and this is another component of our system that really sets us apart. PPN: How do you get patients to opt in without burdening the participating pharmacies? Mr. Cullen: That’s another area where that back-end integration comes in. It enables us to collect data in real time and use that data to streamline the sign-up process, which can take place right at the pharmacy counter. Our goal was to get the sign-up process under 20 seconds, so that we could minimize the impact on the pharmacist or pharmacy technician at any given time. So now, at the point of service, the pharmacist or technician can simply say, “Would you like us to send you a notification when your prescription is ready for pickup? We think it will take 20 minutes to fill but you can go shop or spend time with your family, etc., and we’ll let you know when it’s ready for pickup in the will-call bin.” That may not seem like a big shift in customer service, but it really is significant: Now we’ve enabled the pharmacy to be associated in the patient’s mind with convenience. In essence, we are leveraging the trust the pharmacist already has with that patient, and if we do a good job protecting that trust, we can then build on it by sending textbased messaging out to the patient on an ongoing basis, whether for refills, pickup reminders, dosage reminders, etc. And patients soon realize that the texts are not being sent to harass them or sell them something; they actually represent an opportunity to improve their own health. Once that kicks in, patients respond very quickly and modify their behavior in small ways. And we know that small modifications in behavior can have very large effects overall on medication adherence. PPN: What’s your strategy for getting patients to sign up for video-based education and other disease-specific messaging? Mr. Cullen: It all starts with text messaging and then we build from there.

Once that platform is built, we can go to work understanding what a patient’s prescription list looks like, their refill history, degree of compliance etc. Based on that, we are really good at sending out just the right message at just the right time. Once the patient trusts that process, then it’s relatively easy for us to send out a text telling them that a mobile app for their smartphone is available that they can use to further manage their own and/or their family’s medications in an even more organized and interactive manner. We can also do signage inside the pharmacy; some pharmacies have links to our offerings on their websites, others will do direct advertising, etc. Whatever form the outreach takes, it’s done in a way that strengthens and deepens the trusting relationship that pharmacists and pharmacies have with their patients. PPN: Your system doesn’t take a “one-size-fits-all” approach. Can you explain how it adapts to patient needs? Mr. Cullen: This is again an outgrowth of being integrated with back-end pharmacy systems in a real-time manner. That enables us to tweak our systems and match it to the needs of a patient or pharmacy in a way that’s never been done before. We can now measure the effectiveness of a particular text message, for example, or a particular tactic based on how it’s affecting an individual’s refill behaviors. So we’ll send out text messages with varying content, see how many patients respond, how long it takes them to respond and adjust our messaging accordingly. It’s certainly not a static system, no matter who our client is. Our flu shot messaging has evolved and improved as a result of this process. We realized that [if ] the patient reacts to your texts as an attempt to sell them something, they don’t react well to that. If the message is developed in a manner that first emphasizes the health benefits of getting the flu shot, then the responses are much more favorable. PPN: What can an outpatient hospital pharmacy expect to get out of an mscripts partnership? Mr. Cullen: Our approach gives pharmacies a great tool for strengthening their brand. In fact, you’ll never see an “mscripts” text message, app or website when accessing our systems. Rather, we encourage our partners in pharmacy, whether they are a chain, hospital, specialty pharmacy, etc., to use their own branding when introduc-

Patients using an mscripts-powered mobile app can see all of their prescriptions and dosages in one place. (The participating pharmacy’s name would be used at the top of the app for branding purposes.)

ing these digital programs to patients. But we also realize the decision to bring on any technology comes down to finances, so we help prospective clients understand the return on investment (ROI) they can expect from our system. The factors that can influence ROI are the ones you’d expect, such as reduced returns to stock that result from boosting a pharmacy’s overall refill and pickup rates. But some ROI influencers were actually a surprise to us. In one case, we determined that it was cheaper for one of our pharmacy clients to build a text message into their system that told patients the pharmacy would drive the prescription to their house at a certain time if they could not pick it up on their own. The pharmacy ascertained that it was less expensive for them to pay a driver to deliver the medication than it was for a pharmacist or technician to restock it. PPN: What’s your customer mix like these days? Mr. Cullen: We’re working with 16 different chain pharmacies right now. But we also partner with four outpatient hospital pharmacies, including Henry Ford Hospital in Detroit and Fairview Health Services in Minneapolis, and two specialty pharmacies. In fact, we recently announced a partnership with Pharmacy Advantage, a Michiganbased specialty pharmacy. We built a “PharmAdv” app for them that would not have been possible without our tapping into their EnterpriseRx [McKesson] pharmacy system. We hope that this partnership is the beginning of our becoming a big player in the specialty pharmacy arena, given the huge growth of this practice model. —Reported by David Bronstein

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